Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05042817
Other study ID # VesicalMorphine
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date December 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
100 mcg morphine
The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery
0.9% NaCl
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanil
50 mg prilocaine + 2.5 mcg sufentanil
Procedure:
bilateral transverse abdominal plane block
20 mL of ropicavaine 0.375% on each side

Locations

Country Name City State
Belgium University of Liege, University Hospital Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary First micturition (hours) Vesicle function 1 until the end of the study, an average of 6 months
Primary Bladder volume (mL) Vesicle function 2 until the end of the study, an average of 6 months
Primary Debimetry Vesicle function 3 until the end of the study, an average of 6 months
Secondary Bladder re-catherization Vesicle function 4 until the end of the study, an average of 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A