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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: |
NCT01751256 |
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Date of registration:
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13/12/2012 |
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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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Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia
KTcesar |
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Scientific title:
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Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section. |
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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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68 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01751256 |
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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: Open Label, 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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France
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Contacts
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Name:
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Claude JOLLY, 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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Poissy-Saint Germain Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Scheduled cesarean section
Exclusion Criteria:
- Emergency cesarean section
- Contraindication to opioids, paracetamol, or local anaesthetic
- Ongoing infection
- Coagulation disorders
- Diabetes treated with insulin
- Chronic opioid use
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Feeding
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Anesthesia, Local
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Postoperative Pain
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Intervention(s)
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Device: Continuous wound infiltration
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Primary Outcome(s)
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Postoperative morphine consumption
[Time Frame: 24 first hours after cesarean section]
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Secondary Outcome(s)
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Treatment tolerance
[Time Frame: First 72 hours after skin closure]
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Pain at mobilization
[Time Frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room]
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All cause morbidity
[Time Frame: For the first 10 days after skin closure]
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Early walking
[Time Frame: in the 72 first hours after skin closure]
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Comfort with Breast Feeding
[Time Frame: For the the 48 first hours after skin closure]
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Health staff workload
[Time Frame: For the 48 first hours after skin closure]
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Local anaesthetic systemic toxicity
[Time Frame: During the first 48 hours after skin closure]
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Pain at rest
[Time Frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room]
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Technical problems related to the catheter
[Time Frame: During the 48 first hours after skin closure]
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Maternal satisfaction
[Time Frame: 2 days after skin closure]
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Discomfort due to material
[Time Frame: At catheter retrieval]
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Resumption of gastrointestinal function
[Time Frame: First 72 hours after skin closure]
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Wound infections
[Time Frame: the first 10 days after skin closure]
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Secondary ID(s)
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PoissyStGermainH
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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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