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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01046071 |
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Date of registration:
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08/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy
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Scientific title:
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The Analgesic Efficacy of Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01046071 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Pernille L Petersen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Copenhagen university hospital, Glostrup |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Laparoscopic cholecystectomy
- ASA 1-3
- BMI 18-35
- Written consent
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Laparoscopic Cholecystectomy
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Intervention(s)
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Procedure: TAP block placebo
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Procedure: transversus abdominis plane block
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Primary Outcome(s)
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Pain during cough.
[Time Frame: 0,2,4,6,8,24 hours postoperative]
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Secondary Outcome(s)
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Sedation
[Time Frame: 0,2,4,6,8,24 hours postoperative]
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Postoperative nausea and vomiting
[Time Frame: 0,2,4,6,8,24 hours postoperative]
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Total opioid consumption
[Time Frame: 0-24 hours postoperative]
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Pain during rest
[Time Frame: 0,2,4,6,8,24 hours postoperative]
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Secondary ID(s)
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2009-017420-75
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SM1-plp-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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