Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Apcisaal
Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
1 other identifier
interventional
192
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedResults Posted
Study results publicly available
June 9, 2015
CompletedJune 9, 2015
May 1, 2015
2.5 years
August 25, 2014
April 22, 2015
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Duration of Effective Analgesia
T0 until first request of morphine PCAIV
30 hours after spinal injection T0
Morphine Consumption
Morphine consumption with PCAIV
30 hours after spinal injection T0
Secondary Outcomes (1)
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
30 hours after spinal injection
Study Arms (3)
ropivacaine infiltration
EXPERIMENTALropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
rachi morphine
EXPERIMENTAL100 µg intrathecal morphine and saline infiltration
placebo
PLACEBO COMPARATORintrathecal saline and saline infiltration
Interventions
wound infiltration
100 µg added to the spinal anaesthesia
placebo in spinal anaesthesia and in wound infiltration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Brugmann
Brussels, 1020, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Madeleine Wilwerth
- Organization
- CHU Brugmann
Study Officials
- STUDY DIRECTOR
Philippe Van der Linden, PhD, MD
CHU Brugmann
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
August 25, 2014
First Posted
October 15, 2014
Study Start
February 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
June 9, 2015
Results First Posted
June 9, 2015
Record last verified: 2015-05