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Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

Primary Purpose

Pain, Postoperative

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine bolus in transversus abdominis plane catheter
Bupivacain-infusion in epidural catheter
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Transversus abdominis plane catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients scheduled for open gynecologic surgery
  • acceptance to participate

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids

Sites / Locations

  • Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacain-infusion in epidural catheter

Ropivacaine bolus in transversus abdominis plane catheter

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain-score on numerical rating scale

Secondary Outcome Measures

Administration of opioids
Pain-score on numerical rating scale
Pain-score on numerical rating scale

Full Information

First Posted
July 26, 2012
Last Updated
May 11, 2015
Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01760174
Brief Title
Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
Official Title
A Randomized Double Blind Trial Comparing the Effect of Transversus Abdominal Plane-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Because of logistic and practical reasons.
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Transversus abdominis plane catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacain-infusion in epidural catheter
Arm Type
Active Comparator
Arm Description
Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.
Arm Title
Ropivacaine bolus in transversus abdominis plane catheter
Arm Type
Active Comparator
Arm Description
Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine bolus in transversus abdominis plane catheter
Intervention Description
Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours.
Intervention Type
Drug
Intervention Name(s)
Bupivacain-infusion in epidural catheter
Intervention Description
Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours
Primary Outcome Measure Information:
Title
Pain-score on numerical rating scale
Time Frame
4 hours after first bolus in tranversus abdominis catheters
Secondary Outcome Measure Information:
Title
Administration of opioids
Time Frame
The first 24 hours after surgery.
Title
Pain-score on numerical rating scale
Time Frame
8 hours after first bolus in tranversus abdominis catheters
Title
Pain-score on numerical rating scale
Time Frame
24 hours after first bolus in tranversus abdominis catheters
Other Pre-specified Outcome Measures:
Title
Thermoanalgesia at dermatome-level th10-th12
Time Frame
4 hours after first bolus in TAP-catherter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients scheduled for open gynecologic surgery acceptance to participate Exclusion Criteria: allergies to local analgetics daily use of strong opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils F Bjerregaard, M.D.
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bodil S Rasmussen, M.D. + PhD
Organizational Affiliation
Aalborg Sygehus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lone Nikolajsen, M.D, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas F Bendtsen, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
State/Province
Region Nord
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Comparing the Effect of TAP-catheter and Epidural Catheter on Postoperative Pain After Open Gynecologic Surgery

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