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Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01760161
Recruitment Status : Terminated (No signal on pain-score)
First Posted : January 4, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Nils Bjerregaard, Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Pain-score on numerical rating scale [ Time Frame: 4 hours after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01760161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 2, 2013)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
Official Title  ICMJE 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
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain Treatment
  • Robotic Assisted Laparoscopic Surgery
  • Bilateral Dual Transversus Abdominis Plane Block
Intervention  ICMJE
  • Drug: Ropivacaine
    Ropicacain 3,75 mg/ml 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.
Study Arms  ICMJE
  • Active Comparator: Ropivacain
    Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Isotonic potassium chloride
    Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
    Intervention: Drug: Isotonic potassium chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 2, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • allergies to local analgetics
  • daily use of strong opioids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760161
Other Study ID Numbers  ICMJE 20120042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nils Bjerregaard, Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aalborg University Hospital
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP