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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 75500
      • Aga Khan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Illioinguinal/Illiohypogastric Block; A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given	Procedure: Block/Local infiltration; One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief; Other Names: ILI/IHG Block; Local Infiltration
EXPERIMENTAL: Wound infiltration; Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.	Procedure: Block/Local infiltration; One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief; Other Names: ILI/IHG Block; Local Infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	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.	This was measured at 0 hours (immediately) after the surgery
Pain score	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.	This was measured at 2 hours after the surgery
Pain score	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.	This was measured at 6 hours after the surgery
Pain score	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.	This was measured at 12 hours after the surgery
Pain score	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.	This was measured 24 hours after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tramadol consumption	Amount of total tramadol consumption was recorded	This was measured at 0,2,6,12 and 24 hours after the surgery
Patient satisfaction	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	This was assessed at the end of 24 hours post operatively.

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Summaiya Ali, MBBS, Anesthesia Resident

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2019
• Primary Completion (ACTUAL): June 26, 2019
• Study Completion (ACTUAL): October 25, 2019

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Wounds and Injuries
• Other Study ID Numbers: AgaKhanU1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No