Clinical trial
Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery: A Randomized Double-Blinded Controlled Trial Targeting Patients' Recovery and Satisfaction
Name
2023-3020
Description
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).
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-08-01
Trial end
2023-11-01
Status
Withdrawn
Treatment
Intrathecal Morphine
Patient will receive a spinal anesthesia with a dose of 10.5 mg of bupivacaine 0.75% (1.4 ml),10 mcg of fentanyl (0.2 ml) and 100 mcg of morphine (0.2 ml) for cesarean delivery. At the end of surgery, at wound closure, a 19 Gauge 150 mm catheter will be placed under the fascia and will be linked to an elastometric pump filled with sterile saline (600 ml). A bolus of 20 ml will be administered, and an 8 ml/h infusion will be started. The catheter will be removed at 72 hours.
Arms:
Intrathecal Morphine (Control Group)
Ropivacaine 0.2%
Patient will receive a spinal anesthesia with a dose of 10.5 mg of bupivacaine 0.75% (1.4 ml),10 mcg of fentanyl (0.2 ml) and 100 mcg of morphine (0.2 ml) for cesarean delivery. At the end of surgery, at wound closure, a 19 Gauge 150 mm catheter will be placed under the fascia and will be linked to an elastometric pump filled with sterile saline (600 ml). A bolus of 20 ml will be administered, and an 8 ml/h infusion will be started. The catheter will be removed at 72 hours.
Arms:
Continuous Wound Infusion (Intervention Group)
Primary endpoint
ObsQoR-11 at 24 hours
24 hours after end of surgery
Eligibility criteria
Inclusion Criteria:
* American Society of Anesthesiologists status I and II
* Maternal age above 18 years' old
* Elective cesarean delivery
* Spinal anesthesia
* At least 37 weeks of gestational age
* French-speaking patients (able to read and sign the consent form)
Exclusion Criteria:
* Chronic pain
* Chronic usage of any opioids
* Cardiopathy
* Unexpected difficult spinal anesthesia requiring general anesthesia or unsatisfactory sensory blockade
* Unexpected 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 anesthesia
* Morbid obesity (BMI \> 40 at the time of delivery)
* Active labour
* Emergency CD
* Fetal abnormality or prematurity (\< 37 weeks of gestational age)
* Multiple gestation
* Inability to cooperate due to language or physical/mental incapacity
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blinded and controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Only the anesthesiologist in charge in the operating room will be aware of treatment group.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-02-21
1 organization
2 products
4 indications
Organization
CIUSSS de l'Est de l'Île de MontréalProduct
Intrathecal MorphineIndication
Quality of RecoveryIndication
AnesthesiaIndication
Postoperative PainIndication
c-sectionProduct
Ropivacaine