Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery

University of Liege

Status: Completed

Conditions: Analgesia

Treatments: Drug: 50 mg prilocaine + 2.5 mcg sufentanil; Drug: 100 mcg morphine; Drug: 0.9% NaCl; Procedure: bilateral transverse abdominal plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT05042817

VesicalMorphine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Morphine

Active Comparator group

Description:

50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)

Treatment:

Drug: 50 mg prilocaine + 2.5 mcg sufentanil

Drug: 100 mcg morphine

NaCl 0.9%

Placebo Comparator group

Description:

50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline

Treatment:

Drug: 50 mg prilocaine + 2.5 mcg sufentanil

Procedure: bilateral transverse abdominal plane block

Drug: 0.9% NaCl