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

Sponsor
Egymedicalpedia (Industry)
Overall Status
Completed
CT.gov ID
NCT05549492
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
16.9
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
to determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repairedto determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repaired
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group B

Candidates received 20 ml of 0.25% ropivacaine for TAP block

Drug: 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.
Other Names:
  • buprenorphine 300 μg

    		•
    Experimental: Group RB

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

    Drug: 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.
    Other Names:
  • buprenorphine 300 μg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 October 6 University Hospital Giza Egypt

    Sponsors and Collaborators

    • Egymedicalpedia

    Investigators

    • Principal Investigator: Nirvana Elshalakany, Professor, Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Egymedicalpedia
    ClinicalTrials.gov Identifier:
    NCT05549492
    Other Study ID Numbers:
    • Nirvana Ahmed 01
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hernia
    Pain, Postoperative
    Hernia, Inguinal
    Buprenorphine
    Ropivacaine

    Study Results

    No Results Posted as of Sep 22, 2022