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

Primary Purpose

To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Block/Local infiltration
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Illioinguinal/Illiohypogastric Block

Wound infiltration

Arm Description

A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given

Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Tramadol consumption
Amount of total tramadol consumption was recorded
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

Full Information

First Posted
June 7, 2020
Last Updated
July 7, 2020
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT04462510
Brief Title
To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
Masking
Participant
Masking Description
The patients were randomized using computer generated numbers and did not know which group did they fall in
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Illioinguinal/Illiohypogastric Block
Arm Type
Experimental
Arm Description
A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given
Arm Title
Wound infiltration
Arm Type
Experimental
Arm Description
Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.
Intervention Type
Procedure
Intervention Name(s)
Block/Local infiltration
Other Intervention Name(s)
ILI/IHG Block, Local Infiltration
Intervention Description
One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief
Primary Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
This was measured at 0 hours (immediately) after the surgery
Title
Pain score
Description
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.
Time Frame
This was measured at 2 hours after the surgery
Title
Pain score
Description
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.
Time Frame
This was measured at 6 hours after the surgery
Title
Pain score
Description
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.
Time Frame
This was measured at 12 hours after the surgery
Title
Pain score
Description
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.
Time Frame
This was measured 24 hours after the surgery
Secondary Outcome Measure Information:
Title
Tramadol consumption
Description
Amount of total tramadol consumption was recorded
Time Frame
This was measured at 0,2,6,12 and 24 hours after the surgery
Title
Patient satisfaction
Description
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
Time Frame
This was assessed at the end of 24 hours post operatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Summaiya Ali, MBBS
Organizational Affiliation
Anesthesia Resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sind
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

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