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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: |
NCT02279628 |
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Date of registration:
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16/10/2014 |
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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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Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section
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Scientific title:
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Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study. |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02279628 |
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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), 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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Florence VIAL, MD |
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Address:
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Telephone:
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+33 3 83 34 44 67 |
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Email:
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f.vial@maternite.chu-nancy.fr |
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Affiliation:
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Name:
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Hervé BOUAZIZ, MD., PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France |
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Name:
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Florence VIAL, MD |
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Address:
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Telephone:
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+ 33 3 83 34 43 67 |
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Email:
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f.vial@maternite.chu-nancy.fr |
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Affiliation:
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Name:
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Philippe GUERCI, 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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Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE |
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Name:
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Florence VIAL, 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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Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Elective Cesarean section
- Spinal anesthesia
- Singleton
- ASA ( Physical status score) 1 to 3
Exclusion Criteria:
- Age <18yrs
- BMI = 45 kg/m2 or weight < 45 kg
- Refusal to consent
- Urgent cesarean section
- Allergy to a medication used in the protocol
- Impaired hemostasis ou current infection
- Contra indication or failure of spinal anesthesia
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Female
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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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Drug: Morphine
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Drug: Ropivacaine
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Primary Outcome(s)
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Morphine consumption during the first 48 postoperative hours
[Time Frame: at the 48th hour]
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Secondary Outcome(s)
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Postoperative rehabilitation survey
[Time Frame: At the 48th hour]
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Verbal and Visual analog pain scores in the first standing position
[Time Frame: at day 1]
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Occurrence of side effect
[Time Frame: During the first 48 hours]
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Number of patients that required oral morphine
[Time Frame: At the 24th and 48th hour]
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Number of patients that required local anesthetic rescue dose through the catheter
[Time Frame: At the 24th and 48th hour]
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Pain at rest and at mobilization
[Time Frame: Every 4 hours during the first 48 postoperative hours]
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Postoperative residual pain (DN4 survey)
[Time Frame: At 3 months postoperatively]
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Time to restoration of bowel function
[Time Frame: within the first 48 postoperative hours]
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Secondary ID(s)
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2012-004498-14
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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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