Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Phase 3

Completed

• Conditions: Post Caesarean Analgesia
• Interventions: Drug: intrathecal morphine; Drug: placebo; Drug: ropivacaine infiltration

• Registration Number: NCT02264821
• Lead Sponsor: Dr Madeleine Wilwerth

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%

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-15
• Results First Submitted: 2015-04-22
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Results First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rachi morphine	intrathecal morphine	100 µg intrathecal morphine and saline infiltration
placebo	placebo	intrathecal saline and saline infiltration
ropivacaine infiltration	ropivacaine infiltration	ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

Primary Outcome Measures

Name	Time	Method
Duration of Effective Analgesia	30 hours after spinal injection T0	T0 until first request of morphine PCAIV
Morphine Consumption	30 hours after spinal injection T0	Morphine consumption with PCAIV

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Brugmann; 🇧🇪 Bruxelles, Belgium