Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Study Overview
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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.

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%

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

Conditions
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Post Caesarean Analgesia

Intervention / Treatment
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* Drug: ropivacaine infiltration
* Drug: intrathecal morphine
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine infiltration<br>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline | Drug: ropivacaine infiltration<br>* wound infiltration<br>* Other names: local anesthetic;|
| Experimental: rachi morphine<br>100 µg intrathecal morphine and saline infiltration | Drug: intrathecal morphine<br>* 100 µg added to the spinal anaesthesia<br>* Other names: spinal morphine;|
| Placebo Comparator: placebo<br>intrathecal saline and saline infiltration | Drug: placebo<br>* placebo in spinal anaesthesia and in wound infiltration<br>* Other names: Nacl 0,9 %, saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Effective Analgesia | T0 until first request of morphine PCAIV | 30 hours after spinal injection T0 | 
| Morphine Consumption | 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. | Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus? | 30 hours after spinal injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, caesarean, wound infiltration, intrathecal morphine.