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Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section.
It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric bupivacaine+Sufentanil | Experimental | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg) |
|
| Hyperbaric bupivacaine+morphine | Experimental | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric bupivacaine+Sufentanil | Drug | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section. | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine plus opioid: sufentanil or morphine, produces a longer time for the patient to administer a first analgesic bolus of intravenous morphine. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lower intravenous morphine consumption | 24 hours after surgery | |
| Levels of minor pain verbal scales | The measure is based in EVA (Escala visual analógica del dolor) scale. EVA scale allows to measure the pain intensity that the patient describes with the maximum reproducibility among the observers.
|
| Measure | Description | Time Frame |
|---|---|---|
| Values in the Apgar test | At 1 and 5 minutes after birth |
Inclusion Criteria:
Exclusion Criteria:
The study population will be pregnant women who will undergo elective cesarean section through Subarachnoid anesthesia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La LĆnea | Cadiz | 11300 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2021 | |
| Reset | Mar 23, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2021 | Mar 23, 2021 |
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
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|
| Hyperbaric bupivacaine+Morphine | Drug | To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg) |
|
|
| At 3, 6, 12 and 24 hours after surgery |
| Beginning of sitting and standing | At 48 hours after surgery |
| Mother“s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits. | At intraoperative |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |