Back to resultsWound Infusion vs Spinal Morphine for Post-caesarean Analgesia (Apcisaal)
Primary Purpose
Post Caesarean Analgesia
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
ropivacaine infiltration
intrathecal morphine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Caesarean Analgesia focused on measuring analgesia, caesarean, wound infiltration, intrathecal morphine.
Eligibility 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
Sites / Locations
- Centre Hospitalier Universitaire Brugmann
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ropivacaine infiltration
rachi morphine
placebo
Arm Description
ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
100 µg intrathecal morphine and saline infiltration
intrathecal saline and saline infiltration
Outcomes
Primary Outcome Measures
Duration of Effective Analgesia
T0 until first request of morphine PCAIV
Morphine Consumption
Morphine consumption with PCAIV
Secondary Outcome Measures
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02264821
Brief Title
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Acronym
Apcisaal
Official Title
Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Madeleine Wilwerth
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Caesarean Analgesia
Keywords
analgesia, caesarean, wound infiltration, intrathecal morphine.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ropivacaine infiltration
Arm Type
Experimental
Arm Description
ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
Arm Title
rachi morphine
Arm Type
Experimental
Arm Description
100 µg intrathecal morphine and saline infiltration
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
intrathecal saline and saline infiltration
Intervention Type
Drug
Intervention Name(s)
ropivacaine infiltration
Other Intervention Name(s)
Naropin, local anesthetic
Intervention Description
wound infiltration
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine
Other Intervention Name(s)
spinal morphine
Intervention Description
100 µg added to the spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Nacl 0,9 %, saline solution
Intervention Description
placebo in spinal anaesthesia and in wound infiltration
Primary Outcome Measure Information:
Title
Duration of Effective Analgesia
Description
T0 until first request of morphine PCAIV
Time Frame
30 hours after spinal injection T0
Title
Morphine Consumption
Description
Morphine consumption with PCAIV
Time Frame
30 hours after spinal injection T0
Secondary Outcome Measure Information:
Title
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Description
Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
Time Frame
30 hours after spinal injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Van der Linden, PhD, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
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