Text Size

Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

This study is not yet open for participant recruitment.
Verified January 2013 by Aalborg Universityhospital
Sponsor:
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg Hospital
ClinicalTrials.gov Identifier:
NCT01760161
First received: December 19, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Pain Treatment
Robotic Assisted Laparoscopic Surgery
Bilateral Dual Transversus Abdominis Plane Block
 Drug: Ropivacaine
Drug: Isotonic potassium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Potassium
U.S. FDA Resources

Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Pain-score on numerical rating scale [ Time Frame: 4 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Administration of opioids [ Time Frame: The first 24 hours after surgery. ] [ Designated as safety issue: No ]
  • Pain-score on numerical rating scale [ Time Frame: 8 hours after surgery ] [ Designated as safety issue: No ]
  • Pain-score on numerical rating scale [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Thermoanalgesia at dermatome-level th6-th12 [ Time Frame: 1 hour after bilateral dual transversus abdominis plane block ] [ Designated as safety issue: No ]
  • Plasma-ropivacain level [ Time Frame: 15, 30, 60, 120 and 240 mins after the block ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760161

Contacts
Contact: Nils Bjerregaard, M.D. 004522860649 niheb@rn.dk

Locations
Denmark
Aalborg Hospital Not yet recruiting
Aalborg, Region Nord, Denmark, 9000
Contact: Nils Bjerregaard, M.D     004522860649     niheb@rn.dk    
Sponsors and Collaborators
Aalborg Universityhospital
  More Information

No publications provided

Responsible Party: Nils Bjerregaard, Consultant Anestetist, Aalborg Hospital
ClinicalTrials.gov Identifier: NCT01760161     History of Changes
Other Study ID Numbers: 20120042
Study First Received: December 19, 2012
Last Updated: January 2, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Aalborg Universityhospital:
postoperative pain
opioid consumption
termanalgesia
plasmaropivacain level

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013