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The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
Double blind, 3 groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine infiltration | Experimental | ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline |
|
| rachi morphine | Experimental | 100 µg intrathecal morphine and saline infiltration |
|
| placebo | Placebo Comparator | intrathecal saline and saline infiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine infiltration | Drug | wound infiltration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Effective Analgesia | T0 until first request of morphine PCAIV | 30 hours after spinal injection T0 |
| Morphine Consumption | Morphine consumption with PCAIV | 30 hours after spinal injection T0 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus. | Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus? | 30 hours after spinal injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Van der Linden, PhD, MD | CHU Brugmann | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Brugmann | Brussels | 1020 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine Infiltration | ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration |
| FG001 | Rachi Morphine | 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia |
| FG002 | Placebo | intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine Infiltration | ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration |
| BG001 | Rachi Morphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Effective Analgesia | T0 until first request of morphine PCAIV | Posted | Median | Inter-Quartile Range | minutes | 30 hours after spinal injection T0 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine Infiltration | ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Madeleine Wilwerth | CHU Brugmann | 003224773996 | madeleine.wilwerth@chu-brugmann.be |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000779 | Anesthetics, Local |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| intrathecal morphine | Drug | 100 µg added to the spinal anaesthesia |
|
|
| placebo | Drug | placebo in spinal anaesthesia and in wound infiltration |
|
|
100 µg intrathecal morphine and saline infiltration
intrathecal morphine: 100 µg added to the spinal anaesthesia
| BG002 | Placebo | intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
intrathecal saline and saline infiltration
placebo: placebo in spinal anaesthesia and in wound infiltration
|
|
| Secondary | Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus. | Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus? | Not Posted | 30 hours after spinal injection |
| Primary | Morphine Consumption | Morphine consumption with PCAIV | Posted | Median | Inter-Quartile Range | milligrammes | 30 hours after spinal injection T0 |
|
|
|
| 0 |
| 63 |
| 61 |
| 63 |
| EG001 | Rachi Morphine | 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia | 0 | 61 | 61 | 61 |
| EG002 | Placebo | intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration | 0 | 58 | 58 | 58 |
| Nausea and/or vomiting | Gastrointestinal disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |