Study Stopped
No signal on pain-score
Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
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
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 12, 2015
May 1, 2015
1.7 years
December 19, 2012
May 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain-score on numerical rating scale
4 hours after surgery
Secondary Outcomes (3)
Administration of opioids
The first 24 hours after surgery.
Pain-score on numerical rating scale
8 hours after surgery
Pain-score on numerical rating scale
24 hours after surgery
Other Outcomes (2)
Thermoanalgesia at dermatome-level th6-th12
1 hour after bilateral dual transversus abdominis plane block
Plasma-ropivacain level
15, 30, 60, 120 and 240 mins after the block
Study Arms (2)
Ropivacain
ACTIVE COMPARATORRopicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
Isotonic potassium chloride
PLACEBO COMPARATORIsotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
Interventions
Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
Eligibility Criteria
You may qualify if:
- patients scheduled for robotic assisted laparoscopis 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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 Anestetist
Study Record Dates
First Submitted
December 19, 2012
First Posted
January 4, 2013
Study Start
April 1, 2014
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
May 12, 2015
Record last verified: 2015-05