Assessment of Transversus abdominis plane block for relieving pain associated with laparoscopic inguinal hernia repair in adults

Phase 4

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue, Patients undergoing laparoscopic inguinal hernia repair under general anaesthesia,

• Registration Number: CTRI/2014/07/004748
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Inguinal hernia occurs due to weakness in the anterior abdominal wall muscles and protrusion of the viscera through the inguinal canal. Repair of inguinal hernia involves strengthening/tightening of the anterior abdominal wall muscles by the use of sutures or mesh and excision of the hernia sac. Traditionally a surgical incision and suturing is done with mesh fixation for large or recurrent hernias. Hernia repair surgery is associated with significant post-operative pain.1xml:namespace prefix = o /

The advent of laparoscopic surgery, laparoscopic inguinal hernia repair is now being performed. It is performed by two methods- TEP (Total Extra-Peritoneal repair) and TAPP (Trans Abdominal Pre-Peritoneal repair).   Both involve putting a mesh in the pre-peritoneal space and tacking it to the abdominal wall. The advantages of laparoscopic inguinal hernia repair over open include less dissection of tissue, less pain, less chances of seroma formation, less wound infection and less of superficial skin infection. Laparoscopic hernia repair has definite advantage for bilateral hernias and recurrent hernia repair. Though this avoids need for a big incision and involves just the port site incisions, it is not devoid of pain. The postoperative pain in a laparoscopic hernia repair mostly originates from the skin, where the incision for ports have been given as well as from the peritoneum when it is pulled. This pain is mostly carried by the lower thoracic (T7-T12) and the first lumbar (L1) nerve. Hence blocking these nerves should result in pain relief.

Most of the laparoscopic inguinal hernia repairs are done under general anesthesia. Opioids and NSAIDS are given for pain relief, however their effect, if given during the surgery lasts for only a limited amount of time postoperatively and their dose needs to be repeated to keep the patient pain free. The opioids are not without their side effects, like nausea and vomiting, sedation, urinary retention, ileus, constipation and respiratory depression. The NSAIDS, although considered as highly safe drugs also cause side effects like hepatic and renal toxicity, sedation, dizziness, coagulation abnormalities etc. These side effects add to patient morbidity and delay the discharge of the patient from the hospital2.

Transversus Abdominis Plane (TAP) block blocks the nerves of the anterior abdominal wall T7 to L1, more reliably the T10 to L1 nerves.3 Hence it will be affective in relieving the pain of laparoscopic inguinal hernia repair. The pain originating from the viscera which will theoretically not be blocked by it will usually not be a concern in uncomplicated hernia surgeries. Since it will reduce the post operative opioid consumption it will be helpful in reducing the morbidity due to them as well.

Transversus abdominis plane block has been effectively used for a number of procedures like large bowel resection4.  lower segment caesarean section5,6,7, gyneacological surgeries8,9, laparoscopic cholecystectomies10, renal transplants11, open appendicectomy12, and open hernia repair13.

Although TAP block has been used in open inguinal hernia repair surgeries there is just one case report in which it has been used for laparoscopic inguinal hernia surgery, that too in a unilateral repair14.There have been no conclusive studies regarding its use in bilateral laparoscopic hernia repair. Hence, the need of our study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-16
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

After obtaining institutional, departmental, ethics committee approval and informed written consent, the study will be conducted in 70, ASA Grade I and II, patients aged 18-65years undergoing uncomplicated primary laparoscopic inguinal hernia repair.

Exclusion Criteria

• Following patients will be excluded for the study: 1) Patients who refuse to participate in the study.
• 2. Patients with infection at the site of proposed block 3) Patients having coagulopathy or receiving any anticoagulants.
• 4. Patients allergic to local anaesthetics.
• 5)Patients inability to understand the proper functioning and use of patient controlled analgesia (PCA) device due to any reason.
• 6)Patients whose hernia repair gets converted to open repair.
• 7)Patients with complicated hernias- obstructed, incarcerated or strangulated.
• 8)Patients with high BMI/ morbidly obese 9)Patients on which other surgicalprocedures are being performed concurrently.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the analgesic efficacy of transversus abdominis plane (TAP) block with ropivacaine(0.5%) as compared to port site infiltration with ropivacaine(0.5%) for adult patients undergoing laparoscopic inguinal hernia repair in the first 24 hours postoperatively.	We assess VAS at immediately post op, after shifting to recovery, Then at 1 hr, 2 hr, 4 hr, 6hr and next morning, from 4hr onwards VAS with knee bend and deep breath are also taken. Pain is again assessed at 1 wk and 3 months.

Secondary Outcome Measures

Name	Time	Method
To compare between the 2 groups-	1. intra-operative analgesic (fentanyl) requirement

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Anjolie Chhabra

Principal investigator

9869397814

anjolie5@hotmail.com