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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: Block/Local infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Illioinguinal/Illiohypogastric Block<br>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<br>* One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief<br>* Other names: Local Infiltration;|
| Experimental: Wound infiltration<br>Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed. | Procedure: Block/Local infiltration<br>* One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief<br>* Other names: Local Infiltration;|

What is the study measuring?
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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. |