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

This study has been withdrawn prior to enrollment.
(Because of logistic and practical reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760174
First Posted: January 4, 2013
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg Universitetshospital
  Purpose
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.

Condition Intervention
Pain, Postoperative Drug: Ropivacaine bolus in transversus abdominis plane catheter Drug: Bupivacain-infusion in epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nils Bjerregaard, Aalborg Universitetshospital:

Primary Outcome Measures:
  • Pain-score on numerical rating scale [ Time Frame: 4 hours after first bolus in tranversus abdominis catheters ]

Secondary Outcome Measures:
  • Administration of opioids [ Time Frame: The first 24 hours after surgery. ]
  • Pain-score on numerical rating scale [ Time Frame: 8 hours after first bolus in tranversus abdominis catheters ]
  • Pain-score on numerical rating scale [ Time Frame: 24 hours after first bolus in tranversus abdominis catheters ]

Other Outcome Measures:
  • Thermoanalgesia at dermatome-level th10-th12 [ Time Frame: 4 hours after first bolus in TAP-catherter ]

Enrollment: 0
Study Start Date: January 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacain-infusion in epidural catheter
Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter.
Drug: Bupivacain-infusion in epidural catheter

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

Active Comparator: Ropivacaine bolus in transversus abdominis plane catheter
Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter.
Drug: Ropivacaine bolus in transversus abdominis plane catheter

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.


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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for open gynecologic surgery
  • acceptance to participate

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760174


Locations
Denmark
Aalborg Hospital
Aalborg, Region Nord, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
Aarhus University Hospital
Investigators
Principal Investigator: Nils F Bjerregaard, M.D. Aalborg Universitetshospital
Study Director: Bodil S Rasmussen, M.D. + PhD Aalborg Sygehus
Study Chair: Lone Nikolajsen, M.D, PhD Aarhus University Hospital
Study Chair: Thomas F Bendtsen, MD, PhD Aarhus University Hospital
  More Information

Responsible Party: Nils Bjerregaard, Consultant Anesthetist, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01760174     History of Changes
Other Study ID Numbers: N-20120041
First Submitted: July 26, 2012
First Posted: January 4, 2013
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Nils Bjerregaard, Aalborg Universitetshospital:
Transversus abdominis plane catheter

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents