Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- 100 mcg morphine
- Conditions
- Analgesia
- Sponsor
- University of Liege
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Debimetry
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The enhanced recovery anesthesia concept has been widely adopted, including cesarean delivery. Modern obstetrical anesthesia aims to offer an experience to a patient undergoing a cesarean delivery similar to normal vaginal delivery in order to maximize postoperative comfort and facilitate bonding between the mother and her newborn. Therefore, early removal of the bladder catheter has been recommended. However, this is challenged by the administration of intrathecal morphine recommended to provide long-lasting postoperative analgesia after cesarean delivery.
Detailed Description
This double-blind, randomized trial investigates the effects of intrathecal morphine on urinary dynamics in women undergoing CD under spinal anesthesia. The hypothesis is that the addition of intrathecal morphine (ITM) will delay micturition in women undergoing cesarean delivery. The primary outcome is the effect of ITM on urodynamics the difference in time to micturition. The secondary outcome is the need for bladder re-catheterization.
Investigators
Jean François Brichant
Principal investigator
University of Liege
Eligibility Criteria
Inclusion Criteria
- •ASA physical status I and II
- •Term singleton pregnancies
- •Elective cesarean delivery under spinal anesthesia
- •Between October 2021 and March 2022
Exclusion Criteria
- •Pre-existing or gestational hypertension
- •Cardiovascular disease
- •Cerebrovascular disease
- •Known fetal abnormalities
- •Extremes of weight (\<40 kg or \> 100 kg)
- •Contraindications to neuraxial anesthesia
- •Twin pregnancies
- •Excessive intraoperative bleeding (blood loss exceeding \> 1000 mL or requiring a blood transfusion)
Arms & Interventions
Morphine
50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
Intervention: 100 mcg morphine
Morphine
50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
Intervention: 50 mg prilocaine + 2.5 mcg sufentanil
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
Intervention: 0.9% NaCl
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
Intervention: 50 mg prilocaine + 2.5 mcg sufentanil
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
Intervention: bilateral transverse abdominal plane block
Outcomes
Primary Outcomes
Debimetry
Time Frame: until the end of the study, an average of 6 months
Vesicle function 3
First micturition (hours)
Time Frame: until the end of the study, an average of 6 months
Vesicle function 1
Bladder volume (mL)
Time Frame: until the end of the study, an average of 6 months
Vesicle function 2
Secondary Outcomes
- Bladder re-catherization(until the end of the study, an average of 6 months)