Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

May 11, 2015 updated by: Nils Bjerregaard, Aalborg University Hospital

A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery

To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

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
    • Region Nord
      • Aalborg, Region Nord, Denmark, 9000
        • Aalborg Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for robotic assisted laparoscopis surgery
  • acceptance to participate

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacain
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
Drug: Ropivacaine
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
Placebo Comparator: Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
Drug: Isotonic potassium chloride
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain-score on numerical rating scale
Time Frame: 4 hours after surgery
4 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Administration of opioids
Time Frame: The first 24 hours after surgery.
The first 24 hours after surgery.
Pain-score on numerical rating scale
Time Frame: 8 hours after surgery
8 hours after surgery
Pain-score on numerical rating scale
Time Frame: 24 hours after surgery
24 hours after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Thermoanalgesia at dermatome-level th6-th12
Time Frame: 1 hour after bilateral dual transversus abdominis plane block
1 hour after bilateral dual transversus abdominis plane block
Plasma-ropivacain level
Time Frame: 15, 30, 60, 120 and 240 mins after the block
15, 30, 60, 120 and 240 mins after the block

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

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

April 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120042

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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