Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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%

Conditions

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Post Caesarean Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ropivacaine infiltration

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

Group Type EXPERIMENTAL

ropivacaine infiltration

Intervention Type DRUG

wound infiltration

rachi morphine

100 µg intrathecal morphine and saline infiltration

Group Type EXPERIMENTAL

intrathecal morphine

Intervention Type DRUG

100 µg added to the spinal anaesthesia

placebo

intrathecal saline and saline infiltration

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo in spinal anaesthesia and in wound infiltration

Interventions

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ropivacaine infiltration

wound infiltration

Intervention Type DRUG

intrathecal morphine

100 µg added to the spinal anaesthesia

Intervention Type DRUG

placebo

placebo in spinal anaesthesia and in wound infiltration

Intervention Type DRUG

Other Intervention Names

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Naropin local anesthetic spinal morphine Nacl 0,9 %, saline solution

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No