AnalgesiaNCT05042817
Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery
A study testing 100 mcg morphine, 0.9% NaCl and 50 mg prilocaine + 2.5 mcg sufentanil in people with Analgesia, run by University of Liege at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- 100 mcg morphine, 0.9% NaCl and 50 mg prilocaine + 2.5 mcg sufentanil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I and II
- Term singleton pregnancies
- Elective cesarean delivery under spinal anesthesia
- Between October 2021 and March 2022
Who cannot join
- Pre-existing or gestational hypertension
- Diabetes
- Cardiovascular disease
- Cerebrovascular disease
- Known fetal abnormalities
- Extremes of weight (<40 kg or > 100 kg)
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- Contraindications to neuraxial anesthesia
- Twin pregnancies
- Excessive intraoperative bleeding (blood loss exceeding > 1000 mL or requiring a blood transfusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- 100 mcg morphine, 0.9% NaCl, 50 mg prilocaine + 2.5 mcg sufentanil, bilateral transverse abdominal plane block
- Keywords
- Obstretics, Regional anesthesia, Injections, Spinal, Analgesics, Opioid
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mcg morphineDrug
The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery
0.9% NaClDrug
NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanilDrug
50 mg prilocaine + 2.5 mcg sufentanil
bilateral transverse abdominal plane blockProcedure or surgery
Also called TAP block
20 mL of ropicavaine 0.375% on each side
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | 50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml) Receives: Drug: 100 mcg morphine; Drug: 50 mg prilocaine + 2.5 mcg sufentanil |
| NaCl 0.9% | Placebo comparator | 50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline Receives: Drug: 0.9% NaCl; Drug: 50 mg prilocaine + 2.5 mcg sufentanil; Procedure: bilateral transverse abdominal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
First micturition (hours)
Vesicle function 1
Measured: until the end of the study, an average of 6 months
Bladder volume (mL)
Vesicle function 2
Measured: until the end of the study, an average of 6 months
Debimetry
Vesicle function 3
Measured: until the end of the study, an average of 6 months
Secondary outcomes (1)
Bladder re-catherization
Vesicle function 4
Measured: until the end of the study, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042817
- Sponsor's protocol ID
- VesicalMorphine
- Status last verified
- Mar 2023
- First submitted
- 16 Aug 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05042817
- Acronym / sponsor ID
- VesicalMorphine
- Conditions
- Analgesia
- Keywords
- Obstretics, Regional anesthesia, Injections, Spinal, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: 100 mcg morphine, Drug: 50 mg prilocaine + 2.5 mcg sufentanil50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml) |
| NaCl 0.9% | Placebo comparator | Drug: 0.9% NaCl, Drug: 50 mg prilocaine + 2.5 mcg sufentanil, Procedure: bilateral transverse abdominal plane block50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I and II
- Term singleton pregnancies
- Elective cesarean delivery under spinal anesthesia
- Between October 2021 and March 2022
Key exclusion criteria (9 listed)
- Pre-existing or gestational hypertension
- Diabetes
- Cardiovascular disease
- Cerebrovascular disease
- Known fetal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100 mcg morphineThe effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery | Drug | Morphine |
| 0.9% NaClNaCl 0.9% | Drug | NaCl 0.9% |
| 50 mg prilocaine + 2.5 mcg sufentanil50 mg prilocaine + 2.5 mcg sufentanil | Drug | Morphine, NaCl 0.9% |
| bilateral transverse abdominal plane blockAlso: TAP block20 mL of ropicavaine 0.375% on each side | Procedure or surgery | NaCl 0.9% |
Primary outcome
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
Debimetry
Time frame: until the end of the study, an average of 6 months
Vesicle function 3
1 secondary outcome
Bladder re-catherization
Time frame: until the end of the study, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 mcg morphine, 0.9% NaCl and 50 mg prilocaine + 2.5 mcg sufentanil in people with Analgesia, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First micturition (hours) (time frame: until the end of the study, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023; AzTrials last refreshed its copy on 2 Nov 2026.