Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after laparoscopic surgery on colon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Typical duration for phase_4
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
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 22, 2013
August 1, 2013
2.5 years
June 9, 2011
August 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain during cough
VAS-pain score
6 hours
Secondary Outcomes (3)
Pain during rest
1,2,4,6,12 and 24 hours
Total opioid consumption
0-24 hours
Postoperative nausea and vomiting
1,2,4,6,12,18 and 24 hours
Study Arms (2)
Transversus abdominis plane (TAP) block
EXPERIMENTALTransversus abdominis plane (TAP) block with ropivacaine
Block with saline
PLACEBO COMPARATORBilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Interventions
Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Eligibility Criteria
You may qualify if:
- Age 18 - 80
- BMI 18 - 40
- ASA 1 - 3
- Written consent
- Can cooperate
You may not qualify if:
- Mb Chron and Collitis Ulcerosa
- Drug and alcohol abuse
- Pregnancy
- Consumption of opioids
- Drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herlev University Hospital, Department of anaesthesia
Copenhagen, Herlev, 2730, Denmark
Related Publications (1)
Torup H, Hansen EG, Bogeskov M, Rosenberg J, Mitchell AU, Petersen PL, Mathiesen O, Dahl JB, Moller AM. Transversus abdominis plane block after laparoscopic colonic resection in cancer patients: A randomised clinical trial. Eur J Anaesthesiol. 2016 Oct;33(10):725-30. doi: 10.1097/EJA.0000000000000510.
PMID: 27487909DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
August 16, 2011
Study Start
August 1, 2010
Primary Completion
February 1, 2013
Study Completion
July 1, 2013
Last Updated
August 22, 2013
Record last verified: 2013-08