Phase 3
N=192
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Post Caesarean Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT02264821 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Duration of Effective Analgesia — 351; 380; 247 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ropivacaine infiltration (Drug); intrathecal morphine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dr Madeleine Wilwerth
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Effective Analgesia |
351; 380; 247 | — |
| PRIMARY Morphine Consumption |
8; 4; 20.5 | — |
| SECONDARY Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus. |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02264821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.