Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02264821
NCT02264821
Completed
Phase 3

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

Dr Madeleine Wilwerth1 site in 1 country192 target enrollmentFebruary 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPost Caesarean Analgesia
Interventionsropivacaine infiltrationintrathecal morphineplacebo
Drugsropivacaine infiltrationintrathecal morphineplacebo

Overview

Phase
Phase 3
Intervention
ropivacaine infiltration
Conditions
Post Caesarean Analgesia
Sponsor
Dr Madeleine Wilwerth
Enrollment
192
Locations
1
Primary Endpoint
Duration of Effective Analgesia
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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%

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
August 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Dr Madeleine Wilwerth
Responsible Party
Sponsor Investigator
Principal Investigator

Dr Madeleine Wilwerth

Primary Investigator

Brugmann University Hospital

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
  • •Sleep apnea syndrome and/or obesity (BMI \> 35)
  • •Size inferior to 155cm
  • •existence of a language barrier

Arms & Interventions

ropivacaine infiltration

ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

Intervention: ropivacaine infiltration

rachi morphine

100 µg intrathecal morphine and saline infiltration

Intervention: intrathecal morphine

placebo

intrathecal saline and saline infiltration

Intervention: placebo

Outcomes

Primary Outcomes

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 Outcomes

  • Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.(30 hours after spinal injection)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 4
Analgesic Efficacy of Ropivacaine Alone or in Combination With Adjuvants on Post-operative Analgesia Following Video-Assisted Thoracoscopic Surgery.Postoperative Analgesia
NCT03809442Aga Khan University116
Active, not recruiting
Phase 1
Evaluating the efficacy on pain after a cesarean delivery of a local anesthetic (ropivacaïne) by comparing it with a placebo (NaCl).Poor postoperative pain control leads to decreased satisfaction with care, prolonged recovery time and increased use of health care resources. Despite their efficacy, opioids are associated with nausea, vomiting, pruritus, drowsiness, and the risk for respiratory depression. As an alternatif, continuous wound infusion using a multi-orifice catheter with a local anesthetic has been suggested for pain therapy, however conflicting results are found in randomized controlled trials.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
EUCTR2017-004797-33-BECHU Tivoli68
Completed
Phase 4
Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard AnalgesiaPostoperative PainAnesthesia, LocalBreast Feeding
NCT01751256Poissy-Saint Germain Hospital68
Terminated
Phase 4
Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion SurgeryPostoperative Pain
NCT00823576Centre Hospitalier Universitaire de Nice60
Completed
Phase 4
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee ArthroplastyPostoperative Pain
NCT00408707Hvidovre University Hospital16