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Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

This study has been terminated.
(No signal on pain-score)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760161
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.
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg Universitetshospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • Pain-score on numerical rating scale [ Time Frame: 4 hours after surgery ]

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 surgery ]
  • Pain-score on numerical rating scale [ Time Frame: 24 hours after surgery ]

Other Outcome Measures:
  • Thermoanalgesia at dermatome-level th6-th12 [ Time Frame: 1 hour after bilateral dual transversus abdominis plane block ]
  • Plasma-ropivacain level [ Time Frame: 15, 30, 60, 120 and 240 mins after the block ]

Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (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

Information from the National Library of Medicine

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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 robotic assisted laparoscopis 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): NCT01760161


Locations
Denmark
Aalborg Hospital
Aalborg, Region Nord, Denmark, 9000
Sponsors and Collaborators
Aalborg Universitetshospital
  More Information

Responsible Party: Nils Bjerregaard, Consultant Anestetist, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT01760161     History of Changes
Other Study ID Numbers: 20120042
First Submitted: December 19, 2012
First Posted: January 4, 2013
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Nils Bjerregaard, Aalborg Universitetshospital:
postoperative pain
opioid consumption
termanalgesia
plasmaropivacain level

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents