To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults

Not Applicable

Completed

• Conditions: To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
• Interventions: Procedure: Block/Local infiltration

• Registration Number: NCT04462510
• Lead Sponsor: Aga Khan University

Brief Summary

This study was conducted to assess the postoperative painscores in patients undergoing open inguinal hernia repair between two groups receiving either U/S guided ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves blocks and wound infiltration) was measured alongwith comparison of opioid use between the two groups over 24 hours postoperatively was made. Patient satisfaction between the two groups was also assessed by the Likert scale.

Detailed Description

Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal analgesia is recommended to overcome this issue. Therefore this randomized controlled trial was conducted to compare the analgesic efficacy of ultrasound guided Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.

This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised controlled trial conducted from March 2019 to October 2019. 60 participants for elective unilateral open inguinal hernia repair were included. Patients were randomly allocated (30 each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25% Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site to provide postoperative analgesia. Postoperative pain at rest (static) and on movement (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol consumption and time for first tramadol requirement was noted.

In addition complications related to IHG block and LA infiltration were observed.Patient satisfaction was also gauged by the LIKERT scale in the questionairre.

Study Timeline

• Study Start: 2019-03-30
• Primary Completion: 2019-06-26
• Study Completion: 2019-10-25
• Study First Submitted: 2020-06-07
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients between the ages of 18-75 years, scheduled for unilateral open primary hernia repair electively
• American society of Anaesthesiologists(ASA) standard I to IV

Exclusion Criteria

• BMI below 18 or above 35 kg/m2
• Local anesthetic allergy
• Pregnancy
• Infection at injection site
• Coagulation disorders
• Contraindication to any drug used in the standard anesthesia regimen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Illioinguinal/Illiohypogastric Block	Block/Local infiltration	A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given
Wound infiltration	Block/Local infiltration	Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.

Primary Outcome Measures

Name	Time	Method
Pain score	This was measured 24 hours after the surgery	Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.

Secondary Outcome Measures

Name	Time	Method
Tramadol consumption	This was measured at 0,2,6,12 and 24 hours after the surgery	Amount of total tramadol consumption was recorded
Patient satisfaction	This was assessed at the end of 24 hours post operatively.	This was measured on a 5 point Likert scale. A question was asked that 'was the anesthetic care and pain relief effective?' The scale included the options of Strongly disagree, Disagree, Neutral, Agree, Strongly Agree

Trial Locations

Locations (1)

Aga Khan University Hospital; 🇵🇰 Karachi, Sind, Pakistan