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Clinical Trials/NCT04462510
NCT04462510
Completed
Not Applicable

A Comparison Between Ultrasound Guided Ilioinguial/Iliohyphogastic Nerves Block and Infiltration of Wound With Ropivacaine on Post-Operative Pain After Open Repair of Unilateral Inguinal Hernia in Adults: A Randomized Controlled Trial

Aga Khan University1 site in 1 country60 target enrollmentMarch 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
Sponsor
Aga Khan University
Enrollment
60
Locations
1
Primary Endpoint
Pain score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2019
End Date
October 25, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Summaiya Ahsan Ali

Principal Investigator

Aga Khan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain score

Time Frame: 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 Outcomes

  • Tramadol consumption(This was measured at 0,2,6,12 and 24 hours after the surgery)
  • Patient satisfaction(This was assessed at the end of 24 hours post operatively.)

Study Sites (1)

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