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

May 21, 2015 updated by: Dr Madeleine Wilwerth

Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1020
        • Centre Hospitalier Universitaire Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • spinal morphine
Placebo Comparator: placebo
intrathecal saline and saline infiltration
Drug: placebo
placebo in spinal anaesthesia and in wound infiltration
Other Names:
  • Nacl 0,9 %, saline solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
30 hours after spinal injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Madeleine Wilwerth

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apcisaal 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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