Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia (Apcisaal)

Dr Madeleine Wilwerth

Status and phase: Completed; Phase 3

Conditions: Post Caesarean Analgesia

Treatments: Drug: ropivacaine infiltration; Drug: placebo; Drug: intrathecal morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02264821

Apcisaal 01

Details and patient eligibility

About

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.

Full 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%

Enrollment: 192 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 3 patient groups, including a placebo group

ropivacaine infiltration

Experimental group

Description:

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

Treatment:

Drug: ropivacaine infiltration

rachi morphine

Experimental group

Description:

100 µg intrathecal morphine and saline infiltration

Treatment:

Drug: intrathecal morphine

placebo

Placebo Comparator group

Description:

intrathecal saline and saline infiltration

Treatment:

Drug: placebo