Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia With Nerve Block Versus General Anesthesia: a Randomized Prospective Study
Study Details
Study Description
Brief Summary
Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the most frequently applied method is laparoscopic total extraperitoneal repair (TEP). In general, this surgery is performed under general anesthesia (GA) in many centers. However, in cases where general anesthesia is inconvenient, local or other anesthesia methods are preferred.
It has been stated in many studies in the literature that this surgery can be performed with methods other than general anesthesia. In a study of 480 patients, one of which was Sinha et al., it was shown that this surgical procedure was successfully performed under spinal anesthesia (SA).
In a prospective randomized study by Dönmez et al., patients who underwent TEP under general anesthesia and spinal anesthesia were compared. It has been reported that TEP repair can be performed safely under SA and that SA is associated with less postoperative pain, better recovery, and better patient satisfaction than GA.2 In a retrospective study by Yıldırım et al. It has been shown that there is significantly less need for analgesics and better patient satisfaction.
There are also many meta-analyses made on this subject in the literature. Compared with GA in these, SA was associated with a longer operative time, and postoperative pain and nausea and vomiting were less in SA. However, the risk of urinary retention in SA was significantly increased. It was observed that there was no significant difference in surgical complications such as seroma and wound infection.
Despite all these studies, until now, there is no clear consensus on which anesthesia should be used.
The aim of the study is to compare the results of spinal anesthesia with nerve block and general anesthesia in TEP repair.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Patients who underwent laparoscopic total extraperitoneal (TEP) inguinal hernia repair with the diagnosis of inguinal hernia will be divided into 2 groups. General anesthesia (GA) will be applied to the 1st group, and ileoinguinal (II) and ileohypogastric (IH) nerve block together with spinal anesthesia (SA) to the 2nd group. Randomization will be provided via computer.
The operations will be performed by a single surgeon with at least 3 years of experience in laparoscopic surgery. Randomization will be told to the surgeon only during the operation.
Patients will be followed up by anesthesiologists and surgeons unaware of the randomization, both in the postoperative recovery unit and in the ward.
Patients with an uncomplicated inguinal hernia will be included in the study.
Exclusion criteria:
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Those who have had previous abdominal surgery,
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Incarcerated or strangulated inguinal hernias,
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Recurrent hernias,
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Coagulopathies,
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Patients with musculoskeletal deformity,
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Those with chronic pain,
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Those who use drugs that affect the central nervous system daily,
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Those with a body mass index (BMI) over 40 kg/m2,
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Patients with contraindications to the recommended anesthetic technique.
Preoperative Preparation
Monitoring will be done by electrocardiography, precordial stethoscope, pulse oximetry, and non-invasive blood pressure measurement. Patients will be given a single dose of prophylaxis intravenously with 1 g of cefazolin sodium (Cezol 1 g I.M./I.V. Powder for Injection - 1 Vial) (IV). All laparoscopic surgeries and anesthesia procedures will be performed by the same surgeon and anesthesiologist. All patients will be given detailed information about the procedures to be performed by the anesthetist.
Anesthesia Procedure
General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block.
Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.
Surgical Procedure: The external sheath of the rectus muscle is seen by passing through the skin and subcutaneous tissue with a mini incision made from the umbilicus edge. A 10 mm trocar is placed in the preperitoneal area and CO2 insufflation is performed. The pressure is set to 14 mmHg. Under the guidance of the laparoscope, 2 more 5 mm trocars are inserted between the umbilicus and the sympisis pubis. The preperitoneal inguinal area is dissected with a laparoscopic dissector and grasper. The hernial sac is released. The 10x15 cm prolene mesh is spread and fixed to cover the femoral, direct and indirect hernia areas. The trocars are withdrawn by evacuating the CO2 gas. The skin is closed.
All demographics, American Society of Anesthesiologists (ASA) classification, comorbidities, length of hospital stay, duration of surgery (time from the first incision to the last suture), and duration of anesthesia (time to enter and exit the operating room, minus the operation time) will be recorded. Also, the maximum level of sensory block for group 2 will be recorded. Patients with intraoperative hypotension (<90 mmHg or >30% reduction in baseline mean arterial pressure or systolic arterial pressure), bradycardia (<50/min), and hypoxemia (SpO2 <90%) will be identified and recorded.
The level of pain in the surgical site will be evaluated with a visual analog scale (VAS; 0 = no pain, 10 = severe pain). Pain assessment will be performed first in the postoperative recovery room, then at the postoperative 3rd, 6th and 12th hours and at the time of discharge from the hospital. Adverse postoperative events such as headache, nausea/vomiting, shoulder pain, anxiety, abdominal discomfort and urinary retention will be recorded in both groups. All patients will be asked to fill in the quality of recovery-15 (QoR-15) form.
Intraoperative complications such as vascular or nerve injury, peritoneal laceration, and visceral injury will be recorded. Transitions from TEP to transabdominal preperitoneal (TAPP) repair or open surgery will be recorded.
Bleeding will be recorded as mild if aspiration of the surgical field is not required, moderate if aspiration is required, and severe if blood transfusion is required. Other complications such as hematoma or seroma formation and surgical site infections will also be recorded if they occur.
Statistical Analysis: Considering similar studies in the literature for power analysis, a difference of 1.5 in standard deviation and 0.9 in VAS was found. Considering these data, it was determined that 15 patients per group were required with 80% power and 0.05 type I error. Due to the possibility of losing patients during the study, it was decided to select 17 patients for each group. A total of 34 patients were planned to be included in the study.
Data will be presented as mean (min-max), median (min-max), and numbers. Student's t-test will be used to compare data such as age, gender, duration of surgery, and BMI. The Mann-Whitney test will be used to compare the VAS, the time to the first dose of analgesic, the use of analgesics, the presence of conditions such as postoperative headache, nausea, vomiting, urinary retention, and hospital stay. Fisher's exact test will be used to evaluate ASA. A value of p < 0.05 will be considered statistically significant.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: General anesthesia (GA) Group General anesthesia: No premedication will be applied. In the waiting room, 10 mL/kg of Ringer's lactate solution will be infused IV in 30 minutes. In Group I, 2-2.5 mg/kg propofol and 1 μg/kg fentanyl IV will be given for induction; 0.6 mg/kg rocuronium will then be used to provide the muscle relaxation needed for intubation. After intubation, the tidal volume will be set to 6-8 mL/kg and the respiratory frequency PetCO2 32-36 mmHg in volume-controlled ventilation (VCV) mode. Anesthesia will continue to be provided with sevoflurane (1.5%-2%), oxygen-air mixture (FiO 2 = 0.4) and repeated doses of rocuronium (0.015 mg/kg). At the end of the surgery, neostigmine (2-2.5 mg) and atropine (1 mg) will be given IV to antagonize the residual neuromuscular block. |
Procedure: Spinal anesthesia (with nerve block)
Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.
|
| Active Comparator: Spinal anesthesia (with nerve block) (SA) Group Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine. |
Procedure: Spinal anesthesia (with nerve block)
Spinal Anesthesia and Nerve Block: No premedication will be applied. Spinal anesthesia will be administered to the patients in this group in the sitting position with a 27G Quincke needle (15 mg hyperbaric 0.5% bupivacaine) to be entered through the L2-L3 or L3-L4 interval. If hypotension develops, it will be corrected with a crystalloid infusion and ephedrine. These patients will be administered intravenous sedation with increasing doses of midazolam to provide adequate sedation. According to Hadzic, II and IH nerve block will be performed by applying 10 mL of 0.75% ropivacaine 2 cm above and 2 cm medial to the anterior superior iliac spine.
|
Outcome Measures
Primary Outcome Measures
- Postoperative pain [Postoperative 24 hours]
Visual Analog Score (VAS)
Secondary Outcome Measures
- Adverse postoperative events [Postoperative 24 hours]
headache, nausea/vomiting, anxiety, abdominal discomfort and urinary retention
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with inguinal hernias.
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Over 18 years old
Exclusion Criteria:
-
Younger than 18 years
-
Those who have had previous abdominal surgery,
-
Incarcerated or strangulated inguinal hernias,
-
Recurrent hernias,
-
Coagulopathies,
-
Patients with musculoskeletal deformity,
-
Those with chronic pain,
-
Those who use drugs that affect the central nervous system daily,
-
Those with a body mass index (BMI) over 40 kg/m2,
-
Patients with contraindications to the recommended anesthetic technique.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Health Science Konya City Hospital | Konya | Turkey |
Sponsors and Collaborators
- Konya City Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Donmez T, Erdem VM, Sunamak O, Erdem DA, Avaroglu HI. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study. Ther Clin Risk Manag. 2016 Oct 27;12:1599-1608. doi: 10.2147/TCRM.S117891. eCollection 2016.
- Hajibandeh S, Hajibandeh S, Mobarak S, Bhattacharya P, Mobarak D, Satyadas T. Meta-Analysis of Spinal Anesthesia Versus General Anesthesia During Laparoscopic Total Extraperitoneal Repair of Inguinal Hernia. Surg Laparosc Endosc Percutan Tech. 2020 Aug;30(4):371-380. doi: 10.1097/SLE.0000000000000783.
- Li L, Pang Y, Wang Y, Li Q, Meng X. Comparison of spinal anesthesia and general anesthesia in inguinal hernia repair in adult: a systematic review and meta-analysis. BMC Anesthesiol. 2020 Mar 10;20(1):64. doi: 10.1186/s12871-020-00980-5.
- Sinha R, Gurwara AK, Gupta SC. Laparoscopic total extraperitoneal inguinal hernia repair under spinal anesthesia: a study of 480 patients. J Laparoendosc Adv Surg Tech A. 2008 Oct;18(5):673-7. doi: 10.1089/lap.2007.0219.
- Yildirim D, Hut A, Uzman S, Kocakusak A, Demiryas S, Cakir M, Tatar C. Spinal anesthesia is safe in laparoscopic total extraperitoneal inguinal hernia repair. A retrospective clinical trial. Wideochir Inne Tech Maloinwazyjne. 2017 Dec;12(4):417-427. doi: 10.5114/wiitm.2017.72325. Epub 2017 Dec 29.
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