Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia (Apcisaal)

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ClinicalTrials.gov Identifier: NCT02264821

Recruitment Status : Completed

First Posted : October 15, 2014

Results First Posted : June 9, 2015

Last Update Posted : June 9, 2015

Sponsor:

Information provided by (Responsible Party):

Dr Madeleine Wilwerth, Brugmann University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Post Caesarean Analgesia	Drug: ropivacaine infiltration Drug: intrathecal morphine Drug: placebo	Phase 3

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%

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	192 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
Study Start Date :	February 2012
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nausea and Vomiting Non-Drug Pain Management Wounds and Injuries

Drug Information available for: Morphine sulfate Ropivacaine monohydrochloride

Genetic and Rare Diseases Information Center resources: Agnosia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: ropivacaine infiltration ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline	Drug: ropivacaine infiltration wound infiltration Other Names: Naropin local anesthetic
Experimental: rachi morphine 100 µg intrathecal morphine and saline infiltration	Drug: intrathecal morphine 100 µg added to the spinal anaesthesia Other Name: spinal morphine
Placebo Comparator: placebo intrathecal saline and saline infiltration	Drug: placebo placebo in spinal anaesthesia and in wound infiltration Other Name: Nacl 0,9 %, saline solution

Outcome Measures

Primary Outcome Measures :

Duration of Effective Analgesia [ Time Frame: 30 hours after spinal injection T0 ]
T0 until first request of morphine PCAIV
Morphine Consumption [ Time Frame: 30 hours after spinal injection T0 ]
Morphine consumption with PCAIV

Secondary Outcome Measures :

Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus. [ Time Frame: 30 hours after spinal injection ]
Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264821

Locations

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Belgium
Centre Hospitalier Universitaire Brugmann
Bruxelles, Belgium, 1020

Sponsors and Collaborators

Dr Madeleine Wilwerth

Investigators

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Study Director:	Philippe Van der Linden, PhD, MD	CHU Brugmann

More Information

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Responsible Party:	Dr Madeleine Wilwerth, Primary Investigator, Brugmann University Hospital
ClinicalTrials.gov Identifier:	NCT02264821
Other Study ID Numbers:	Apcisaal 01
First Posted:	October 15, 2014 Key Record Dates
Results First Posted:	June 9, 2015
Last Update Posted:	June 9, 2015
Last Verified:	May 2015

Keywords provided by Dr Madeleine Wilwerth, Brugmann University Hospital:


analgesia caesarean wound infiltration intrathecal morphine.

Additional relevant MeSH terms:

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Agnosia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Morphine Ropivacaine Anesthetics, Local	Anesthetics Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents

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