The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy

NCT ID: NCT01046071

Last Updated: 2011-11-18

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Keywords

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Transversus abdominis plane block, postoperative pain.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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transversus abdominis plane block

transversus abdominis plane block with ropivacaine

Group Type EXPERIMENTAL

transversus abdominis plane block

Intervention Type PROCEDURE

UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.

block with saline

20 ml of isotonic saline bilateral

Group Type PLACEBO_COMPARATOR

TAP block placebo

Intervention Type PROCEDURE

UL-guided TAP block with 20 ml of saline bilaterally, single dose.

Interventions

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transversus abdominis plane block

UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.

Intervention Type PROCEDURE

TAP block placebo

UL-guided TAP block with 20 ml of saline bilaterally, single dose.

Intervention Type PROCEDURE

Other Intervention Names

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Naropine Postoperative pain UL-guided nerve block placebo block

Eligibility Criteria

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Inclusion Criteria

* Laparoscopic cholecystectomy
* ASA 1-3
* BMI 18-35
* Written consent

Exclusion Criteria

* Do not understand danish
* Drug allergy
* Pregnancy
* Alcohol or drug abuse
* Chronic pain with consumption of opioids
* Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation
* Infection at the needle site.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Pernille Lykke Petersen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernille L Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Glostrup

Locations

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Glostrup University Hospital, Department of anesthesia

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2009-017420-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM1-plp-09

Identifier Type: -

Identifier Source: org_study_id