Trial on TAP Block After Bariatric Surgery

NCT03411772 | Completed

• 1 other identifier: mansourau44
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Postoperative abdominal pain

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

  first 24 hours after surgery

Study Arms (2)

TAP block

ACTIVE COMPARATOR

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

Procedure: TAP block; Procedure: Bariatric surgery

Non TAP block

SHAM COMPARATOR

Patients undergoing bariatric surgery without having TAP block

Procedure: Bariatric surgery

Interventions

TAP block PROCEDURE

Injection of 20 mL of 0.25% bupivacaine in the transversus abdominis plane under ultrasound guidance after performing bariatric surgery

TAP block

Bariatric surgery PROCEDURE

Bariatric surgery will be conducted

Non TAP block; TAP block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Sameh H Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 26, 2018
• Study Start: January 10, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 15, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)