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
About this trial
This is an interventional treatment trial for Inguinal Hernia
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.
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
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
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Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
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