Analgesia
Conditions
Keywords
Obstretics, Regional anesthesia, Injections, Spinal, Analgesics, Opioid
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.
Interventions
DRUG100 mcg morphine
The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery
DRUG0.9% NaCl
NaCl 0.9%
DRUG50 mg prilocaine + 2.5 mcg sufentanil
50 mg prilocaine + 2.5 mcg sufentanil
20 mL of ropicavaine 0.375% on each side
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patient assessments and bladder urodynamic data collection were performed by two blinded anesthesiologists. Randomization was performed using the sealed envelopes method. Therefore, one of the anesthesiologists of the research team, who was unblinded, opened the envelopes and prepared the injection mixtures. Another two blinded anesthesiologists administered perioperative anesthesia and monitored the patient during the perioperative period, and evaluated sensitive and motor block.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * Diabetes * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First micturition (hours) | until the end of the study, an average of 6 months | Vesicle function 1 |
| Bladder volume (mL) | until the end of the study, an average of 6 months | Vesicle function 2 |
| Debimetry | until the end of the study, an average of 6 months | Vesicle function 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder re-catherization | until the end of the study, an average of 6 months | Vesicle function 4 |
Countries
Belgium
Outcome results
None listed