Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery

Phase 1

Completed

• Conditions: Pain, Postoperative; Inguinal Hernia
• Interventions: Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

• Registration Number: NCT05549492
• Lead Sponsor: Egymedicalpedia

Brief Summary

Buprenorphine intravenous, sublingual, and transdermal patches have been researched for their antihyperalgesic effects, although peripherally mediated effects have not been examined in Egypt surprisingly

Detailed Description

This prospective, randomized, double-blind controlled trial involved 88 patients who were scheduled for inguinal hernia surgery followed by a TAP block. Patients were allocated into group B (n= 44) received 20 ml of 0.25% Ropivacaine for TAP block; group BR (n= 44) received 20 ml of 0.25% Ropivacaine containing 300 μg of buprenorphine for TAP Block. The primary outcome of the study was the analgesic and antihyperalgesic effect of buprenorphine compared to the control group. The duration of analgesia, analgesic consumption, postoperative pain scores at rest and sitting up to 48 hrs, and effect on wound hyperalgesia at 24 and 48 hrs were evaluated. Secondary outcomes of the study include incidence of side effects and TAP block-related complications were recorded. Effect of buprenorphine on patients with predicted high pain scores and incidence of persistent postoperative pain were also determined.

A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Patients with Inguinal Hernia
2. Medically free

Exclusion Criteria

1. participants with a history of heart, renal and liver cell failure.
2. allergic reaction to studied drugs, and history of epilepsy,
3. hydrodynamic instability,
4. chronic pain.
5. mental illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RB	Ropivacaine 0.25%-NaCl 0.9% Injectable Solution	Candidates received 20 ml of 0.25% ropivacaine and 300 μg of buprenorphine, respectively, for the TAP block.
Group B	Ropivacaine 0.25%-NaCl 0.9% Injectable Solution	Candidates received 20 ml of 0.25% ropivacaine for TAP block

Primary Outcome Measures

Name	Time	Method
Post Operative Pain	2 hours after the operation upto 48-hour analgesic after surgery	The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Giza, Egypt