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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462510
• Other study ID #: AgaKhanU1
• Status: Completed
• Phase: N/A
• Start date: March 30, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: July 2020
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
• Wounds and Injuries

Intervention

Procedure:
• Block/Local infiltration
One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Tramadol consumption	Amount of total tramadol consumption was recorded	This was measured at 0,2,6,12 and 24 hours after the surgery
Secondary	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.