Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Information source: Brugmann University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Caesarean Analgesia
Intervention: ropivacaine infiltration (Drug); intrathecal morphine (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Dr Madeleine Wilwerth Official(s) and/or principal investigator(s):
Philippe Van der Linden, PhD, MD, Study Director, Affiliation: CHU Brugmann
Summary
The aim of this study is to compare effective analgesia with continuous wound infiltration
of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to
spinal anesthesia, after elective Caesarean delivery.
Clinical Details
Official title: Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Duration of Effective AnalgesiaMorphine Consumption
Secondary outcome: Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Detailed description:
Double blind, 3 groups
- Control group: Rachi 0,1 ml saline, Infusion 300ml saline
- Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
- Group KT: 0,1 ml saline/300 ml naropin 0. 2%
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of
gestational age, admitted for a planned caesarian with a Pfannenstiel incision and
having signed the informed consent form.
Exclusion Criteria:
- Refusal of the patient or contra-indication to locoregional anesthesia
- Allergy to the products used
- ASA 3
- ASA 4
- Sleep apnea syndrome and/or obesity (BMI > 35)
- Size inferior to 155cm
- existence of a language barrier
Locations and Contacts
Centre Hospitalier Universitaire Brugmann, Bruxelles 1020, Belgium
Additional Information
Starting date: February 2012
Last updated: May 21, 2015
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