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Clinical Trials/NCT01760174
NCT01760174
Withdrawn
Not Applicable

A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

Aalborg University Hospital1 site in 1 countryJanuary 2016

Overview

Phase
Not Applicable
Intervention
Bupivacain-infusion in epidural catheter
Conditions
Pain, Postoperative
Sponsor
Aalborg University Hospital
Locations
1
Primary Endpoint
Pain-score on numerical rating scale
Status
Withdrawn
Last Updated
10 years ago

Overview

Brief Summary

This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.

Detailed Description

Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters. The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12. The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nils Bjerregaard

Consultant Anesthetist

Aalborg University Hospital

Eligibility Criteria

Inclusion Criteria

  • patients scheduled for open gynecologic surgery
  • acceptance to participate

Exclusion Criteria

  • allergies to local analgetics
  • daily use of strong opioids

Arms & Interventions

Bupivacain-infusion in epidural catheter

Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.

Intervention: Bupivacain-infusion in epidural catheter

Ropivacaine bolus in transversus abdominis plane catheter

Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.

Intervention: Ropivacaine bolus in transversus abdominis plane catheter

Outcomes

Primary Outcomes

Pain-score on numerical rating scale

Time Frame: 4 hours after first bolus in tranversus abdominis catheters

Secondary Outcomes

  • Administration of opioids(The first 24 hours after surgery.)
  • Pain-score on numerical rating scale(24 hours after first bolus in tranversus abdominis catheters)

Study Sites (1)

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