The Effects of Laparoscopic Guided Transversus Abdominis Plane (TAP) Block in Sleeve Gastrectomy Procedure.

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-02-15

Brief Summary

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Sleeve gastrectomy is the most performed bariatric procedure worldwide. Postoperative pain management is a challenging issue. In this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (TAP) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.

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Detailed Description

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TAP block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. In that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. Therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.

Conditions

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Obesity, Morbid Postoperative Pain Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Forty patients had divided into two groups; TAP block group (TAP-B) and placebo (P) group. Every group contained 20 patients and randomization was performed by sealed envelope method. Patient and the data collector resident didn't know the which procedure was done thus single-blinded randomization were provided.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TAP Block

In this group ,TAP block will be performed with 0.5% 15 ml bupivacaine + 5 ml .

Group Type EXPERIMENTAL

Transversus abdominis plane block

Intervention Type PROCEDURE

TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Placebo

In this group , 20 ml saline solution will injected into the transversus abdominis plane.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Interventions

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Transversus abdominis plane block

TAP block will be performed by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Intervention Type PROCEDURE

Placebo

20 ml saline solution will be injected by a needle which is punctured at the midaxillary line between subcostal margin and iliac crest, once tip of the needle had detected just above the peritoneum the syringe pulled back.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients between 18-65
* undergo Laparoscopic sleeve gastrectomy

Exclusion Criteria

* Bupivacaine allergy
* having chronic pain or taking pain management
* ASA ( The American Society of Anesthesiologists Physical Classification System) Class 4 or
* Patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No