search
Back to results

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

Primary Purpose

Inguinal Hernia, Pain, Postoperative

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • October 6 University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group B

Group RB

Arm Description

Candidates received 20 ml of 0.25% ropivacaine for TAP block

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

Outcomes

Primary Outcome Measures

Post Operative Pain
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)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2022
Last Updated
September 19, 2022
Sponsor
Egymedicalpedia
search

1. Study Identification

Unique Protocol Identification Number
NCT05549492
Brief Title
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Official Title
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
to determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repaired
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Experimental
Arm Description
Candidates received 20 ml of 0.25% ropivacaine for TAP block
Arm Title
Group RB
Arm Type
Experimental
Arm Description
Candidates received 20 ml of 0.25% ropivacaine and 300 μg of buprenorphine, respectively, for the TAP block.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
Other Intervention Name(s)
buprenorphine 300 μg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Operative Pain
Description
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)
Time Frame
2 hours after the operation upto 48-hour analgesic after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Inguinal Hernia Medically free Exclusion Criteria: participants with a history of heart, renal and liver cell failure. allergic reaction to studied drugs, and history of epilepsy, hydrodynamic instability, chronic pain. mental illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirvana Elshalakany, Professor
Organizational Affiliation
Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University Hospital
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs