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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: |
NCT01577940 |
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Date of registration:
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21/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Method Study: Bilateral TAP Block With 24 Hours Infusion
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Scientific title:
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Method Study of Bilateral Transversus Abdominis Plane (TAP) Block With 24 Hours Infusion. Extent of Sensory Block, Analgetic Effect and Lung Function in Healthy Volunteers |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01577940 |
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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: Efficacy Study, Intervention Model: Crossover 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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HOC, anesthesiology, Rigshospitalet, Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age between 18 and 30 years
- written consent
- ASA 1
- BMI between 18 and 25
- males
Exclusion Criteria:
- unable to communicate in Danish
- relevant drug allergy
- alcohol or/and drug abuse
- daily intake of prescription pain medication the last 4 weeks
- pain medication in the last 48 hours
- previously operated abdominal
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Procedure: Infusion of ropivacaine
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Procedure: Infusion of saline
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Primary Outcome(s)
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Change in extend of sensory block from baseline (pre block) to 24 hours post block, based on 6 measurements
[Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block]
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Secondary Outcome(s)
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Long Thermal stimulation (abdomen)
[Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block]
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Lung function
[Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block]
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Heat pain detection threshold (abdomen)
[Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block]
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Heat pain detection threshold (dominant forearm)
[Time Frame: -15 min., 1, 4, 8, 12 and 24 hours following TAP block]
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Secondary ID(s)
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SM1-PLP-11
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2011-005118-13
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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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