Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery

NCT ID: NCT01418144

Last Updated: 2013-08-22

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

2010-08-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.

Detailed Description

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Conditions

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Laparoscopic Colon Surgery

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 (TAP) block

Transversus abdominis plane (TAP) block with ropivacaine

Group Type EXPERIMENTAL

Transversus abdominis plane (TAP) block

Intervention Type PROCEDURE

Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%

Block with saline

Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane

Group Type PLACEBO_COMPARATOR

Placebo TAP block

Intervention Type PROCEDURE

Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane

Interventions

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Transversus abdominis plane (TAP) block

Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%

Intervention Type PROCEDURE

Placebo TAP block

Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane

Intervention Type PROCEDURE

Other Intervention Names

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Naropin Placebo block

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 80
* BMI 18 - 40
* ASA 1 - 3
* Written consent
* Can cooperate

Exclusion Criteria

* Mb Chron and Collitis Ulcerosa
* Drug and alcohol abuse
* Pregnancy
* Consumption of opioids
* Drug allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Herlev University Hospital, Department of anaesthesia

Copenhagen, Herlev, Denmark

Site Status

Countries

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Denmark

References

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Torup H, Hansen EG, Bogeskov M, Rosenberg J, Mitchell AU, Petersen PL, Mathiesen O, Dahl JB, Moller AM. Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial. Eur J Anaesthesiol. 2016 Oct;33(10):725-30. doi: 10.1097/EJA.0000000000000510.

Reference Type DERIVED
PMID: 27487909 (View on PubMed)

Other Identifiers

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SM1-HT-2010

Identifier Type: -

Identifier Source: org_study_id