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

NCT ID: NCT05549492

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-05-30

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

Conditions

Inguinal Hernia; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group B

Candidates received 20 ml of 0.25% ropivacaine for TAP block

Group Type: EXPERIMENTAL

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Intervention Type: DRUG

The 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.

Group RB

Candidates received 20 ml of 0.25% ropivacaine and 300 μg of buprenorphine, respectively, for the TAP block.

Group Type: EXPERIMENTAL

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

Intervention Type: DRUG

The 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.

Interventions

Ropivacaine 0.25%-NaCl 0.9% Injectable Solution

The 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.

Intervention Type: DRUG

Other Intervention Names

buprenorphine 300 μg

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nirvana Elshalakany, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

Locations

October 6 University Hospital

Giza, , Egypt

Countries

Egypt

Other Identifiers

Nirvana Ahmed 01

Identifier Type: -

Identifier Source: org_study_id