Trial on TAP Block After Bariatric Surgery

NCT ID: NCT03411772

Last Updated: 2018-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-10-15

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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TAP block

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

Group Type ACTIVE_COMPARATOR

TAP block

Intervention Type PROCEDURE

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

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery will be conducted

Non TAP block

Patients undergoing bariatric surgery without having TAP block

Group Type SHAM_COMPARATOR

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery will be conducted

Interventions

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TAP block

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

Intervention Type PROCEDURE

Bariatric surgery

Bariatric surgery will be conducted

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansourau44

Identifier Type: -

Identifier Source: org_study_id

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