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

August 21, 2013 updated by: Copenhagen University Hospital at Herlev

Effect of Transversus Abdominis Plane (TAP) Block as Postoperative Pain Management After Laparoscopic Colon Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Herlev
      • Copenhagen, Herlev, Denmark, 2730
        • Herlev University Hospital, Department of anaesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transversus abdominis plane (TAP) block
Transversus abdominis plane (TAP) block with ropivacaine
Procedure: Transversus abdominis plane (TAP) block
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
Other Names:
  • Naropin
PLACEBO_COMPARATOR: Block with saline
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Procedure: Placebo TAP block
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Other Names:
  • Placebo block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during cough
Time Frame: 6 hours
VAS-pain score
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during rest
Time Frame: 1,2,4,6,12 and 24 hours
VAS-pain score at rest
1,2,4,6,12 and 24 hours
Total opioid consumption
Time Frame: 0-24 hours
Opioid consumption via PCA-pump.
0-24 hours
Postoperative nausea and vomiting
Time Frame: 1,2,4,6,12,18 and 24 hours
Nausea score 0-3 No. of vomits
1,2,4,6,12,18 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-HT-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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