The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy
2 other identifiers
interventional
80
1 country
1
Brief Summary
The purpose of this study is to determine whether Transversus abdominis plane block as part of a multimodal postoperative regimen is superior to control in analgesic efficacy after laparoscopic cholecystectomy.
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 Mar 2010
Shorter than P25 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
First Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedNovember 18, 2011
November 1, 2011
11 months
January 8, 2010
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain during cough.
Area under the curve (AUC)-pain during cough based on measurements at 0,2,4,6,8,24 hours postoperative.
0,2,4,6,8,24 hours postoperative
Secondary Outcomes (4)
Pain during rest
0,2,4,6,8,24 hours postoperative
Total opioid consumption
0-24 hours postoperative
Postoperative nausea and vomiting
0,2,4,6,8,24 hours postoperative
Sedation
0,2,4,6,8,24 hours postoperative
Study Arms (2)
transversus abdominis plane block
EXPERIMENTALtransversus abdominis plane block with ropivacaine
block with saline
PLACEBO COMPARATOR20 ml of isotonic saline bilateral
Interventions
UL-guided TAP block with 20 ml of ropivacaine 0,5% bilateral, single dose.
UL-guided TAP block with 20 ml of saline bilaterally, single dose.
Eligibility Criteria
You may qualify if:
- Laparoscopic cholecystectomy
- ASA 1-3
- BMI 18-35
- Written consent
You may not qualify if:
- Do not understand danish
- Drug allergy
- Pregnancy
- Alcohol or drug abuse
- Chronic pain with consumption of opioids
- Consumption of NSAID, COX2inhibitors or paracetamol within 24 hours before the investigation
- Infection at the needle site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glostrup University Hospital, Department of anesthesia
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pernille L Petersen, MD
Glostrup University Hospital, Copenhagen
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
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 11, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
November 18, 2011
Record last verified: 2011-11