Comparison of open and laparoscopic total extraperitoneal inguinal hernia repair under blocked spinal anesthesia and general anesthesia

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RESEARCH ARTICLE

Hippokratia 2024, 28(4): 143-149

Ulutaş ME1, Yılmaz AH2, Sakar HA3
1Department of General Surgery, Derecik State Hospital, Hakkari
2Department of General Surgery, University of Health Sciences, Van Training and Research Hospital, Van
3Department of Anesthesiology and Reanimation, University of Health Sciences, Van Training and Research Hospital, Van
Turkey

Abstract

Background: Using different anesthesia methods, we aimed to compare the intraoperative and early postoperative effects of laparoscopic and open inguinal hernia repair techniques.

Methods: We enrolled 68 patients with inguinal hernia into the study, randomly assigned to total extraperitoneal (TEP) repair and Lichtenstein procedures with a 1:1 ratio. Subsequently, we randomly assigned groups’ participants into two subgroups with a 1:1 ratio: those receiving ilioinguinal (II) and iliohypogastric (IH) nerve block with spinal anesthesia (SA group) and those receiving general anesthesia (GA group). We recorded demographic characteristics, clinical features, and surgical site pain levels at the first, fourth, 12th, and 24th postoperative hours [measured using a visual analog scale (VAS)], and compared data between the four groups.

Results: We did not modify any patient’s surgical or anesthetic technique planned. We observed no difference in the operative time between the groups (p =0.81). The percentage of patients who experienced pain during surgery was 41.2 % (n =7) in the TEP-SA group and 17.6 % (n =3) in the Open-SA group (p =0.13). In these cases, operations were safely completed with additional sedoanalgesia. Intraoperative complications, such as hypertension, tachycardia, and bradycardia, occurred in only three patients (17.6 %) in the TEP-SA group (p =0.95). When we analyzed postoperative complications, headaches developed in one patient (5.9 %) in the TEP-SA group and in three patients (17.6 %) in the Open-SA group (p =0.95). The lowest VAS value at postoperative first, fourth, and 12th hours was observed in the TEP-SA group (p <0.001).

Conclusions: The present study investigated the effects of anesthesia type and the surgical method for inguinal hernia, and the results showed that the TEP procedure performed under SA was the best combination because of its positive effects during surgery and in the early postoperative period. HIPPOKRATIA 2024, 28 (4):143-149. 

Keywords: Inguinal hernia, laparoscopic, spinal, general, anesthesia, block

Corresponding author: Mehmet Eşref Ulutaş, MD, Affiliation: Department of General Surgery, Derecik State Hospital, Hastane Caddesi, Derecik/ Hakkari, Turkey, tel: +905074769036, fax: +904322220010, e-mail: esref_ulutas@hotmail.com

Introduction

Inguinal hernia repair is a common general surgical procedure, and similar to other open surgical procedures, it can also be performed laparoscopically. Open techniques such as the Lichtenstein procedure, anterior preperitoneal repair, the Shouldice, and Kugel and Stoppa procedures can be mentioned. The most commonly used laparoscopic techniques include total extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair. In terms of the clinical course of the patients, both during surgery and in the postoperative period, the choice of the anesthesia method is as important as the choice of surgical technique. Regional anesthesia has advantages such as faster postoperative recovery, a more hemodynamically stable course, and less response to surgical stress1. Laparoscopic hernia repairs have better cosmetic outcomes, earlier recovery and return to work, and less postoperative pain than traditional open surgical methods2.

Open procedures, such as Lichtenstein, are typically performed under local or regional anesthesia methods, whereas laparoscopic procedures, such as TEP, are generally conducted under general anesthesia (GA) to avoid pain and distension caused by carbon dioxide (CO2) insufflation3. The necessity of GA limits the use of the TEP procedure, especially in patients with comorbidities. Unfortunately, despite the many advantages the TEP method provides to the patient surgically, these advantages cannot be accomplished from an anesthesia perspective when GA is used. Therefore, numerous studies have been conducted to enable laparoscopic techniques to be performed using anesthesia methods other than GA. However, there is no clear consensus on this issue. As stated in systematic reviews on this subject, better quality randomized clinical trials are required to define the efficacy of regional anesthesia in TEP hernia repair4. Therefore, we aimed to determine the effects of both the anesthetic method and the surgical procedure on patients undergoing surgery for inguinal hernia during the early postoperative period. An additional approach not previously implemented in other studies was also utilized in this study in the spinal anesthesia (SA) group, which involved adding II and IH nerve blocks to enhance the effectiveness of anesthesia. The primary endpoint was to achieve more effective perioperative analgesia and patient comfort with the nerve block added to SA and to demonstrate whether the operation could be completed with the planned surgical and anesthetic method. The secondary endpoints were to demonstrate this approach’s efficacy on perioperative and postoperative vital signs and its effects on postoperative pain control. 

Material-Methods

Trial Design

We conducted this prospective randomized study in the General Surgery Department of Van Training and Research Hospital in accordance with the CONSORT guideline5. Approval was obtained from the Clinical Research Ethics Committee of the University of Health Sciences, Van Training and Research Hospital (decision No 2023/19-03, date: 13/09/2023). All human procedures were conducted according to the 1964 Declaration of Helsinki, and we obtained written informed consent from all participants. This study was registered with ClinicalTrials.gov (NCT05837013). 

Participants and eligibility criteria

We enrolled in the study patients planned to be operated on with a diagnosis of inguinal hernia between September 2023 and January 2024. We defined the presence of a unilateral inguinal hernia in adult (age >18 years) men or women as inclusion criteria and excluded cases with bilateral hernias, incarcerated or strangulated hernias, previous abdominal surgery, recurrent hernias, coagulopathies, patients with musculoskeletal deformities, with contraindications to the proposed anesthetic technique, chronic pain, with a body mass index (BMI) above 40 kg/m2, and using daily medications that affect the central nervous system6. 

Randomization

The sixty-eight study participants were randomly assigned to the TEP and Lichtenstein procedure groups with a 1:1 ratio through a computer-generated randomization sequence. Subsequently, we further randomly assigned groups’ participants into two subgroups (SA and GA) with a 1:1 ratio using the same method. No additional procedure was performed in the GA subgroup, while II and IH nerve blocks were applied in the SA subgroup. The randomization outcome was communicated to the surgeon and anesthesiologist at the beginning of the operation. The same surgeons and anesthesiologists performed surgeries and anesthesia procedures and had at least three years of experience in their respective fields.

Surgeons and anesthesiologists who were not involved in the operation monitored patients in the postoperative recovery unit and on the ward and also conducted patients’ post-discharge follow-ups. 

Preoperative preparation

We closely monitored all patients’ vital signs and administered a single dose of cefazolin sodium intravenously (Cezol 1 gram vial) for prophylaxis. We informed in detail all patients regarding the procedures to be performed by the anesthesiologist. 

General anesthesia

We administered no premedication and performed intravenous induction with 2-2.5 mg/kg propofol and 1 μg/kg fentanyl followed by 0.6 mg/kg rocuronium. After intubation, we adjusted the tidal volume to 6-8 mL/kg, respiratory rate to end-tidal carbon dioxide partial pressure (PetCO2) 32-36 mmHg, and initiated volume-controlled ventilation mode. We maintained anesthesia with sevoflurane (1.5-2 %), oxygen-air mixture [fraction of inspired oxygen (FiO2) =0.4], and repeated doses of rocuronium (0.015 mg/kg). We initiated paracetamol 15 mg/kg and tramadol 10 mg/kg as intravenous infusion when the trocars were removed or the skin incision commenced to be sutured. At the end of the surgery, sevoflurane was discontinued. After spontaneous respiratory effort began, we intravenously administered neostigmine (2-2.5 mg) and atropine (1 mg) to antagonize residual neuromuscular blockade. The patient was taken to the recovery room and subsequently transferred to the ward with an Aldrete scoring system of 10 points.

Spinal anesthesia and nerve block

We administered no premedication and intravenously infused Ringer’s lactate solution (10 mL/kg) in the waiting room for over 30 minutes. Patients in this group received SA using a 27G Quincke tip spinal needle with 15 mg of 0.5 % bupivacaine injected at the L2-L3 or L3-L4 interspace in the sitting position. We used bolus crystalloid infusion and ephedrine to correct hypotension if it developed. We performed a sensory examination and confirmed the T6 sensory block level. The plane between the transverse abdominis and internal oblique muscles was visualized with an 18 MHz linear probe under ultrasonographic guidance. We confirmed localization with a 1 ml 0.09 % NaCl test dose. We injected with a 100 mm 20 G peripheral block needle a mixture of 15 ml 0.5 % bupivacaine and 5 ml 0.09 % NaCl (total 20 ml) and monitored the distribution of the local anesthetic solution. After the operation, it was planned to administer 1-3 mg midazolam and 50-150 mcg fentanyl intravenously, with spontaneous breathing monitoring, to patients who felt mild to moderate pain or had deterioration in vital signs such as hypertension, tachycardia, or bradycardia. In patients who developed tachycardia and hypertension, it was planned to administer additional sedoanalgesia if there was an increase of up to 10 % compared to the patient’s baseline values and to switch to GA if there was an increase of more than 10 %. However, the necessary preparations were in place to switch to GA if patients felt severe pain at the operation site and were extremely uncomfortable/agitated due to pain which is secondary to diaphragmatic irritation that results from CO2 insufflation. In these patients, firstly the pressure pneumoperitoneum was reduced to 10 mmHg, and additional sedoanalgesia was applied. It was planned to change the method of anesthesia and switch to general anesthesia afterward (see GA procedure).

TEP procedure

We made a mini-incision at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. We incised the rectus sheath and laterally displaced the rectus muscle. We inserted a 10-mm trocar into the preperitoneal space and performed CO2 insufflation with a pressure set at 12 mmHg. We inserted two additional 5 mm trocars between the umbilicus and the symphysis pubis under laparoscopic guidance. We performed all steps of myopectineal orifice dissection using laparoscopic dissectors and graspers7. A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. We removed the trocars under camera surveillance after CO2 desufflation, and the skin was closed. 

Open technique (Lichtenstein)

Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, we placed a polypropylene mesh measuring approximately 60 x 110 mm2 to cover the transverse fascia completely. We used continuous sutures to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed.

Parameters evaluated

We recorded for all patients their demographic characteristics, American Society of Anesthesiologists (ASA) classification, comorbidities, length of hospital stay, and operative time (from the initial incision to the last skin suture). Additionally, we recorded the maximum sensory block level for patients undergoing SA. We also monitored and recorded intraoperative events such as hypotension (defined as a mean arterial pressure <90 mmHg or >30 % decrease from baseline), hypertension (systolic pressure >160 mmHg or diastolic pressure <100 mmHg or mean arterial pressure >30 % increase from baseline), bradycardia (heart rate <50 beats/min), and hypoxemia [peripheral oxygen saturation (SpO2) <90 %]. We assessed the surgical site pain level using VAS (0 =no pain, 10 =severe pain). Initially, we conducted pain assessment in the recovery room at one hour postoperatively, followed by assessments at the fourth, 12th, and 24th postoperative hours. We recorded in all patients adverse events such as headache, pain, nausea/vomiting, feeling of discomfort, urinary retention, and anxiety. All patients, regardless of whether they had GA or LA, were administered parenteral paracetamol and oral acetaminophen as analgesia. Moreover, tramadol was administered intravenously to patients with VAS ≥4 from the 4th postoperative hour in the GA group and the 6th postoperative hour in the SA group.

We recorded intraoperative complications (vascular and nerve injuries, peritoneal laceration (pneumoperitoneum), and visceral injury) and documented cases of conversion from TEP to TAPP repair or open surgery.

Bleeding was recorded as mild, moderate, or severe if no aspiration of the surgical site was required, and any other complication (hematoma or seroma formation and surgical site infections) was also documented.

Statistical Analysis

Based on similar studies in the literature, a standard deviation of 1.5 resulted in a VAS score difference of 0.98. We conducted a power analysis based on these data, and the minimum sample size per group was calculated as 15 patients with 80 % power and a type I error rate of 0.05. We decided to enroll 17 patients for each group to account for the possibility of dropouts during the study, and therefore, we included 68 patients in the study.

We utilized the Kolmogorov-Smirnov and Shapiro-Wilk tests to assess the normality of the variable distribution and used non-parametric tests for non-normally distributed variables. Subsequently, we used the Mann–Whitney U test to compare the variables obtained from the measurements between groups and the chi-square and Fisher’s exact tests to analyze the relationships or differences between groups regarding categorical variables. We conducted multiple group comparisons using ANOVA analysis and applied the Bonferroni and Tamhane-T2 tests depending on whether the variances were homogeneous. We used repeated measures ANOVA to compare repeated measurements like VAS and hemodynamic variables. We present comparative results between groups based on other demographic characteristics as a ratio of qualitative variables and express quantitative variables as mean and standard deviation. We used the IBM SPSS Statistics for Windows, Version 22.0 (IBM Corp., Armonk, NY, USA) for statistical analysis. A p-value of less than 0.05 was considered significant.

Results

A total of 68 patients, 17 patients in each group, participated in the study (Figure 1, flow diagram). Table 1 provides detailed demographic information and hernia characteristics of the participants. We did not modify any patient’s surgical or anesthetic technique planned, and the surgeries were completed accordingly.

Figure 1: Flow diagram showing the enrollment according to the inclusion and exclusion criteria, randomization into groups and subgroups, and analysis of 68 eligible patients who underwent inguinal hernia repair in this prospective study.
TEP: total extraperitoneal, Open: open surgical procedure, GA: general anesthesia, SA: spinal anesthesia.

Operative time was between 31.3 and 33.4 minutes (p =0.81). Patients’ proportion of experiencing pain during surgery was 41.2 % (n =7) and 17.6 % (n =3) in the TEP repair and Lichtenstein repair groups, respectively (p =0.13). Patients’ proportion of receiving additional sedoanalgesia during surgery was 29.4 % (n =5) in the TEP repair group and 17.6 % (n =3) in the Lichtenstein repair group (p =0.34). The incidence of pneumoperitoneum was 17.6 % (n =3) in the SA group and 35.3 % (n =6) in the GA group (p =0.22). All intraoperative complications occurred in the TEP-SA group and no intraoperative complications occurred in the other groups (p =0.40). The duration of hospital stay was one day for all patients. The time to return to normal activity was between 6.6 and 7.6 hours (p =0.17). The follow-up duration was longest in the TEP-GA group and shortest in the open-GA group (p <0.001). In terms of postoperative complications, one patient (5.9 %) in the TEP-SA group and three patients (17.6 %) in the open-SA group had headaches. No other complications occurred in any group (p =0.95). Additionally, there were no incidences of shoulder pain, urinary retention, nausea, vomiting, or bleeding in any of the patients. All surgical and anesthetic data are provided in Table 2.

Intraoperative VAS scores were 3.5 ± 2.6 and 2.2 ± 2.02 in the TEP-SA and Open-SA groups, respectively (p =0.11). When postoperative VAS scores were evaluated, the lowest value at the first, fourth, 12th, and 24th postoperative hours was in the TEP-SA group (p <0.001). Table 3 provides detailed comparisons of VAS scores between the groups.

Discussion

Inguinal hernia repair is performed using open and closed techniques. However, there is no standard approach regarding either the surgical technique or the anesthesia method. It is well known that laparoscopic hernia repair offers advantages over other methods, such as reduced postoperative pain, faster recovery, and better cosmetic outcomes. Similarly, regional or local anesthesia techniques have advantages such as faster recovery, less postoperative nausea and vomiting, less hemodynamic changes, and decreased metabolic response to surgical stress.

The anesthetic and surgical techniques concerning inguinal hernia repair have been investigated in several studies. Sunamak et al reported that performing laparoscopic hernia repair techniques under SA was the most advantageous method in terms of pain compared to both open techniques and GA8. However, it is unclear whether this advantage stems from the surgical technique or the anesthesia method. Sayadishahraki et al successfully performed the TEP procedure under SA9. In a prospective randomized study, Dönmez et al demonstrated that TEP repair was safely performed under SA and reported that SA was associated with less postoperative pain, patient satisfaction, and better recovery compared to GA10. In addition to these findings, several studies demonstrated that patients undergoing TEP procedures under SA experience significantly less postoperative pain in the early period, require substantially fewer analgesics, and report better patient satisfaction11-13. Similarly, the present study observed the lowest pain levels at one, four, and 12 hours postoperatively in patients undergoing TEP under SA. These results support the notion that regional anesthesia and laparoscopic surgical techniques have a positive impact on patients, as indicated in previous studies. When laparoscopy and regional anesthesia methods are applied together, patients feel less postoperative pain. However, the absence of a difference in pain levels beyond 24 hours suggests that this effect is particularly prominent in the early postoperative period.

In a meta-analysis, SA was associated with longer operative time14, and in another meta-analysis, it was reported that the SA group was disadvantaged in terms of operative time15. However, no significant difference was found in operative time between the four groups in the present study, probably attributed to the effect of II and IH nerve blocks performed in addition to SA, which resulted in less pain during surgery and increased patient comfort.

Previous studies have either performed nerve blocks in addition to GA or applied them in open surgical techniques. For instance, in one study where transverse abdominis plane block and rectus sheath block were applied under GA in laparoscopic inguinal hernia surgery, it was reported that patients who received the block exhibited faster recovery and healing in the postoperative period16. Onur et al also reported that II nerve block had positive effects on postoperative pain and early discharge in patients undergoing open inguinal hernia repair under SA17. However, we note that the application of II and IH nerve blocks in addition to SA in the present study further strengthened the effect of SA in laparoscopic techniques such as TEP.

Previous studies have reported no difference between the two methods regarding surgical complications such as seroma and wound infections15. One study reported a significant increase in the overall risk of urinary retention following SA8. In another study, vomiting occurred postoperatively in 2.08 % of patients who underwent SA compared to 30.61 % of patients who underwent GA12. A meta-analysis reported that postoperative nausea, pain, and vomiting were less common in the SA group14; however, no cases of urinary retention, nausea, or vomiting were observed in the present study. No other complications occurred except for headaches in four patients in the SA groups, and no significant difference was observed among the groups regarding postoperative complications; however, these results may be due to our study’s small number of cases.

In previous studies, there have been situations in laparoscopic hernia repairs where a conversion from SA to GA was deemed necessary. There have also been cases where conversion from laparoscopic procedures to open procedures has been required. Lal et al reported factors such as pneumoperitoneum, shoulder pain, intraoperative difficulty, and inadequate preperitoneal space as factors leading to conversion from SA to GA1. The rate of conversion to GA due to anesthesia failure was reported to be 0.76 %, while the rate of conversion to open surgery was reported to be 0.2 %. Arya et al reported that in 5 out of 33 cases, regional anesthesia had to be converted to GA due to intraoperative reasons such as hypotension, shoulder pain, pneumoperitoneum, difficulty, and/or inadequate preperitoneal space12. In another study where TEP repair was performed under SA, no necessary conversion to GA was reported9. Prevention and treatment of pneumoperitoneum and subsequent shoulder pain are regarded as the most crucial means to prevent conversions1. In the present study, pain during surgery occurred in seven patients undergoing TEP under SA and three patients undergoing the Lichtenstein procedure. The pain experienced by the patients in the SA-TEP group was not located in the surgical site pain but discomfort due to diaphragmatic irritation. Additional sedoanalgesia was administered to five patients who underwent the TEP procedure and to all three patients who underwent the Lichtenstein procedure, allowing surgery to be successfully completed without changing surgical or anesthesia techniques. In cases where the effects of SA and nerve blocks were insufficient, experienced surgeons were able to quickly complete these procedures with additional sedoanalgesia. Additionally, in the present study, pneumoperitoneum developed in three patients in the TEP-SA group and in six patients in the TEP-GA group. However, these events did not pose substantial concerns, necessitating changes in surgical or anesthesia techniques.

The most commonly reported intraoperative complication of SA was hypotension in previous studies. However, it was generally manageable with medical treatment4. Kale et al reported the rate of hypotension as 28.9 % in the hernia group receiving spinal anesthesia18. A systematic review reported that hypotension was observed in 19 % of patients undergoing TEP under SA19. In the present study, hypertension, tachycardia, and bradycardia developed in three patients who underwent the TEP procedure under SA, and no other intraoperative complications occurred. These patients were managed medically, and the procedures were successfully completed without changing the anesthesia techniques.

All patients were hospitalized for one day and discharged the following day. The time they returned to routine activities, such as walking and caring for their bathroom needs, was similar across all groups. When the early outcomes of TEP or Lichtenstein procedures performed under the same anesthesia method were examined, TEP performed under SA was found more advantageous in pain than the Lichtenstein procedure performed under SA. However, this assertion could not be made for procedures performed under GA, as TEP and Lichtenstein’s procedures yielded similar outcomes regarding pain in these patients. One of the limitations of the present study was the short follow-up period. However, we aimed to demonstrate the early effects of anesthesia and surgical techniques on the patients. Thus, long-term follow-up of patients has not been recorded.

Data recorded intraoperatively and early VAS assessment as leg moving is not fully restored up to four hours postoperatively could not collected in a fully blinded manner. For this reason, our study could not be completely blinded, which constitutes our most important limitation.

Conclusion

The most significant finding of the present study, where both the anesthesia and surgical methods were compared across four different groups, is that the most advantageous method for hernia repair was the TEP procedure performed under SA, both during surgery and in the early postoperative period, due to its effects on pain and hemodynamics. The pain experienced by the patients in the SA-TEP group was not located in the surgical site pain but was discomfort due to diaphragmatic irritation. This was overcome by lowering the pressure pneumoperitoneum and additional sedoanalgesia. In addition, the positive effects of adding II and IH nerve blocks in this group could not be overstated during the postoperative period. Our study did not identify a previously reported increase in postoperative morbidity and longer operative time associated with this method. Therefore, this combined approach can be safely preferred in inguinal hernia procedures.

Conflict of interest

The authors have no conflicts of interest to declare.

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