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Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Information source: Brugmann University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Caesarean Analgesia

Intervention: ropivacaine infiltration (Drug); intrathecal morphine (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dr Madeleine Wilwerth

Official(s) and/or principal investigator(s):
Philippe Van der Linden, PhD, MD, Study Director, Affiliation: CHU Brugmann

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Duration of Effective Analgesia

Morphine Consumption

Secondary outcome: Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.

Detailed description: Double blind, 3 groups

- Control group: Rachi 0,1 ml saline, Infusion 300ml saline

- Group rachi-morphine: 0,1ml =100g morphine/300ml saline

- Group KT: 0,1 ml saline/300 ml naropin 0. 2%

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Centre Hospitalier Universitaire Brugmann, Bruxelles 1020, Belgium
Additional Information

Starting date: February 2012
Last updated: May 21, 2015

Page last updated: August 23, 2015

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