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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: |
NCT01052285 |
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Date of registration:
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19/01/2010 |
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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 Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair
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Scientific title:
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The Efficacy of Transversus Abdominis Plane Block Versus Placebo Versus Local Infiltration in Patients Undergoing Groin Hernia Repair in Day Case Surgery. |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01052285 |
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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: 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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Glostrup University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18-75 years old
- groin hernia repair
- written consent
- ASA 1-3
- BMI 18-35
Exclusion Criteria:
- unable to communicate in Danish
- relevant drug allergy
- pain medication in the last 24 hours
- pregnancy
- alcohol or/and drug abuse
- daily opioid intake
- infection at injection 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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Hernia
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Intervention(s)
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Procedure: Local infiltration
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Procedure: Saline
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Procedure: Transversus abdominis plane block
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Primary Outcome(s)
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Pain scores by coughing between TAP block group and placebo group
[Time Frame: 0,2,4,6,8,19 and 24 hours postoperative]
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Secondary Outcome(s)
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Pain scores at rest between TAP block versus placebo and TAP block versus infiltration and infiltration versus placebo
[Time Frame: 0,2,4,6,8,19,24 hours postoperative]
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Total opioid consumption
[Time Frame: 0-24 hours postoperative]
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Postoperative nausea and vomiting
[Time Frame: 0,2,4,6,8,19,24 hours postoperative]
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Pain scores by coughing between placebo and local infiltration and between TAP block and local infiltration.
[Time Frame: 0,2,4,6,8,19 and 24 hours postoperative]
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Sedation
[Time Frame: 0,2,4,6,8,19,24 hours postoperative]
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Secondary ID(s)
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2010-018403-29
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SM1-plp-10
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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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