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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

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%

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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


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




Primary Outcome Measures :
  1. Duration of Effective Analgesia [ Time Frame: 30 hours after spinal injection T0 ]
    T0 until first request of morphine PCAIV

  2. Morphine Consumption [ Time Frame: 30 hours after spinal injection T0 ]
    Morphine consumption with PCAIV


Secondary Outcome Measures :
  1. 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?



Information from the National Library of Medicine

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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

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
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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
Signs and Symptoms
Morphine
Ropivacaine
Anesthetics, Local
Anesthetics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents