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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intrathecal Morphine for Cesarean Delivery

NCT05069012

Postoperative Pain

COMPLETED PHASE4

Analgesic Effects of Intrathecal Morphine and Bilateral Erector Spina Plane Block in Elective Cesarean Section

NCT05698927

Opioid Use Postoperative Pain

COMPLETED NA

A Randomized Controlled Trial Comparing Intrathecal Morphine with Quadratus Lumborum Block for Post-cesarean Delivery Analgesia

NCT02871713

Cesarean Section

COMPLETED NA

Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.

NCT06442995

Urinary Retention

RECRUITING PHASE4

Decreased Neuraxial Morphine After Cesarean Delivery

NCT04279054

Anesthesia

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Morphine

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

Group Type ACTIVE_COMPARATOR

100 mcg morphine

Intervention Type DRUG

The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery

50 mg prilocaine + 2.5 mcg sufentanil

Intervention Type DRUG

50 mg prilocaine + 2.5 mcg sufentanil

NaCl 0.9%

50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline

Group Type PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type DRUG

NaCl 0.9%

50 mg prilocaine + 2.5 mcg sufentanil

Intervention Type DRUG

50 mg prilocaine + 2.5 mcg sufentanil

bilateral transverse abdominal plane block

Intervention Type PROCEDURE

20 mL of ropicavaine 0.375% on each side

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

100 mcg morphine

The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery

Intervention Type DRUG

0.9% NaCl

NaCl 0.9%

Intervention Type DRUG

50 mg prilocaine + 2.5 mcg sufentanil

Intervention Type DRUG

bilateral transverse abdominal plane block

20 mL of ropicavaine 0.375% on each side

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TAP block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No