Clinical Trials Directory

Trials / Completed

CompletedNCT05549492

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Egymedicalpedia · Industry
Sex
All
Age
30 Years – 45 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGRopivacaine 0.25%-NaCl 0.9% Injectable SolutionThe pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present.

Timeline

Start date
2021-01-01
Primary completion
2022-05-01
Completion
2022-05-30
First posted
2022-09-22
Last updated
2022-09-22

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05549492. Inclusion in this directory is not an endorsement.