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Trial on TAP Block After Bariatric Surgery

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TAP block
Bariatric surgery
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All morbidly obese patients of both genders with BMI >35 kg/m2 who will be admitted to the General Surgery Department within the study period to undergo laparoscopic bariatric procedures will be included in this study. Bariatric procedures to be performed will comprise LSG, roux en-Y- gastric bypass, mini-gastric bypass, gastric plication, and single anastomosis sleeve ileal (SASI) bypass.

Exclusion Criteria:

  • Patients unfit for general anesthesia, patients with secondary obesity due to endocrine disorders, patients with psychiatric disorders, patients with drug abuse or history of opioid intake or chronic pain disorder, patients with contraindication to peripheral nerve block such as allergy to local anesthetics and coagulopathy.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TAP block

Non TAP block

Arm Description

Patients undergoing bariatric surgery having TAP block upon completion of the procedure

Patients undergoing bariatric surgery without having TAP block

Outcomes

Primary Outcome Measures

Postoperative abdominal pain
Degree of postoperative pain measured by Visual Analogue Scale from 0-10

Secondary Outcome Measures

Full Information

First Posted
January 14, 2018
Last Updated
December 3, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03411772
Brief Title
Trial on TAP Block After Bariatric Surgery
Official Title
Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Pain After Laparoscopic Bariatric Surgery: a Randomized Double Blind Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

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

5. Study Description

Brief Summary
Patients undergoing bariatric surgery will be divided randomly into two groups: the first will have TAP block upon completion of surgery and the second groups will not have TAP block.
Detailed Description
Upon completion of the laparoscopic bariatric procedure to be performed for every patient and just before recovery from general anesthesia, an ultrasound-guided TAP block will be conducted in the operative theater by the anesthetist for group I patients whereas group II will be recovered from anesthesia without having a TAP block. The ultrasound probe will be placed on the lateral abdominal wall in the mid-axillary line between the lower costal margin and iliac crest. Using ultrasound will allow accurate deposition of the local anesthetic in the correct neurovascular plane. A spinal needle will be advanced using in-plane technique between the aponeurosis of the internal oblique and transversus abdominis muscles. With intermittent aspiration, 20 mL of local anesthetic (0.25% bupivacaine) will be deposited in the TAP on each side and seen as a hypoechoic shadow pushing the two layers apart.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Patients will sign an informed consent entailing their knowledge and acceptance of being included in the trial, however patients will not be aware to the group they will be included to. In addition, the operating surgeon will not be aware to the nature of the study.
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
Patients undergoing bariatric surgery having TAP block upon completion of the procedure
Arm Title
Non TAP block
Arm Type
Sham Comparator
Arm Description
Patients undergoing bariatric surgery without having TAP block
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
Injection of 20 mL of 0.25% bupivacaine in the transversus abdominis plane under ultrasound guidance after performing bariatric surgery
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Bariatric surgery will be conducted
Primary Outcome Measure Information:
Title
Postoperative abdominal pain
Description
Degree of postoperative pain measured by Visual Analogue Scale from 0-10
Time Frame
first 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All morbidly obese patients of both genders with BMI >35 kg/m2 who will be admitted to the General Surgery Department within the study period to undergo laparoscopic bariatric procedures will be included in this study. Bariatric procedures to be performed will comprise LSG, roux en-Y- gastric bypass, mini-gastric bypass, gastric plication, and single anastomosis sleeve ileal (SASI) bypass. Exclusion Criteria: Patients unfit for general anesthesia, patients with secondary obesity due to endocrine disorders, patients with psychiatric disorders, patients with drug abuse or history of opioid intake or chronic pain disorder, patients with contraindication to peripheral nerve block such as allergy to local anesthetics and coagulopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial on TAP Block After Bariatric Surgery

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