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NCT05696678
Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery
Conditions: Quality of Recovery, Anesthesia, Postoperative Pain, Cesarean Section
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 96
Sponsor: Ciusss de L'Est de l'Île de Montréal
Location: Canada
Summary
The purpose of this prospective randomized double-blinded and controlled study is to evaluate the quality of recovery after elective cesarean delivery using the Obstetric Quality-of-Recovery-11 (ObsQoR-11) score at 24 hours between patients receiving intrathecal morphine (ITM group) compared to patients receiving a ropivacaine continuous wound infusion (CWI group).
Eligibility Criteria
Inclusion Criteria:American Society of Anesthesiologists status I and IIMaternal age above 18 years' oldElective cesarean deliverySpinal anesthesiaAt least 37 weeks of gestational ageFrench-speaking patients (able to read and sign the consent form)Exclusion Criteria:Chronic painChronic usage of any opioidsCardiopathyUnexpected difficult spinal anesthesia requiring general anesthesia or unsatisfactory sensory blockadeUnexpected complications requiring strong hemodynamic support (transfusions, volume challenges, multiple vasopressors, inotropic drugs…) or requiring anti-hypertensive medication (including magnesium)Any contraindication (e.g.
coagulopathy) or patient's refusal for spinal anesthesiaMorbid obesity (BMI > 40 at the time of delivery)Active labourEmergency CDFetal abnormality or prematurity (< 37 weeks of gestational age)Multiple gestationInability to cooperate due to language or physical/mental incapacity
Source: ClinicalTrials.gov (NCT05696678). StuddyBuddy aggregates publicly available trial information.