NCT01760174

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
3 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

July 26, 2012

Last Update Submit

May 11, 2015

Conditions

Pain, Postoperative

Keywords

Transversus abdominis plane catheter

Outcome Measures

Primary Outcomes (1)

  • Pain-score on numerical rating scale

    4 hours after first bolus in tranversus abdominis catheters

Secondary Outcomes (3)

  • Administration of opioids

    The first 24 hours after surgery.

  • Pain-score on numerical rating scale

    8 hours after first bolus in tranversus abdominis catheters

  • Pain-score on numerical rating scale

    24 hours after first bolus in tranversus abdominis catheters

Other Outcomes (1)

  • Thermoanalgesia at dermatome-level th10-th12

    4 hours after first bolus in TAP-catherter

Study Arms (2)

Bupivacain-infusion in epidural catheter

ACTIVE COMPARATOR

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

Drug: Bupivacain-infusion in epidural catheter

Ropivacaine bolus in transversus abdominis plane catheter

ACTIVE COMPARATOR

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

Interventions

Ropivacaine bolus in transversus abdominis plane catheterDRUG

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.

Ropivacaine bolus in transversus abdominis plane catheter
Bupivacain-infusion in epidural catheterDRUG

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

Bupivacain-infusion in epidural catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for open gynecologic surgery
  • acceptance to participate

You may not qualify if:

  • allergies to local analgetics
  • daily use of strong opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg Hospital

Aalborg, Region Nord, 9000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nils F Bjerregaard, M.D.

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

  • Bodil S Rasmussen, M.D. + PhD

    Aalborg Sygehus

    STUDY DIRECTOR

  • Lone Nikolajsen, M.D, PhD

    Aarhus University Hospital

    STUDY CHAIR

  • Thomas F Bendtsen, MD, PhD

    Aarhus University Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthetist

Study Record Dates

First Submitted

July 26, 2012

First Posted

January 4, 2013

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

DK(1)