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

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Egymedicalpedia

Status and phase

Completed
Phase 1

Conditions

Pain, Postoperative
Inguinal Hernia

Treatments

Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT05549492
Nirvana Ahmed 01

Details and patient eligibility

About

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

Full 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

Enrollment

64 patients

Sex

All

Ages

30 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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