OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients

NCT ID: NCT03954795

Last Updated: 2019-05-21

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-08-31

Brief Summary

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The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and OSTAP in patients undergoing laparoscopic cholecystectomy.

Detailed Description

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Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1: Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was induced and maintained in all patients. At the end of the operation patient controlled analgesia with morphine was applied to all patients.

Pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption and pain scores were compared.

Conditions

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Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1: TAP Block

TAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)

Group Type ACTIVE_COMPARATOR

TAP

Intervention Type PROCEDURE

Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)

Group 2: OSTAP Block

Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

Group Type ACTIVE_COMPARATOR

OSTAP

Intervention Type PROCEDURE

Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

No Block

No interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TAP

Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)

Intervention Type PROCEDURE

OSTAP

Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled for laparoscopic cholecystectomy
* ASA status I-II

Exclusion Criteria

* Local anesthetic allergy
* Coagulopathy
* Infection at procedure site
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Sagir, MD

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BAUA

Identifier Type: -

Identifier Source: org_study_id

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