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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine | Active Comparator | 50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml) |
|
| NaCl 0.9% | Placebo Comparator | 50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mcg morphine | Drug | The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| First micturition (hours) | Vesicle function 1 | until the end of the study, an average of 6 months |
| Bladder volume (mL) | Vesicle function 2 | until the end of the study, an average of 6 months |
| Debimetry | Vesicle function 3 | until the end of the study, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder re-catherization | Vesicle function 4 | until the end of the study, an average of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women with term singleton pregnancies are included, therefore males cannot be included
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Liege, University Hospital | Liège | 4000 | Belgium |
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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.
| 0.9% NaCl | Drug | NaCl 0.9% |
|
| 50 mg prilocaine + 2.5 mcg sufentanil | Drug | 50 mg prilocaine + 2.5 mcg sufentanil |
|
| bilateral transverse abdominal plane block | Procedure | 20 mL of ropicavaine 0.375% on each side |
|
|
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D000077330 | Saline Solution |
| D011318 | Prilocaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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