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The aim of this study was to determine whether the addition of esketamine to morphine would improve postoperative analgesia after caesarean section.
Parturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C and D). When the surgery was completed, the parturients in groups A, B, C and D were administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural catheters, respectively. The postoperative pain at rest, pain with movement, the number of rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter. |
|
| group B | Active Comparator | The parturients in group B were administered 0.25mg/kg of esketamine. |
|
| group C | Active Comparator | The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate. |
|
| group D | Active Comparator | The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 mg morphine sulfate | Drug | The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Two hours after caesarean delivery |
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Four hours after caesarean delivery |
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Eight hours after caesarean delivery |
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Twelve hours after caesarean delivery |
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Twenty-four hours after caesarean delivery |
| Postoperative pain score at rest | The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) | Two hours after caesarean delivery |
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qijun Ran | Dazhou | Sichuan | 636150 | China |
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| 0.25mg/kg esketamine | Drug | The parturients were administered 0.25mg/kg of esketamine through the epidural catheter. Sterile saline was added to make a total volume of 8 mL. |
|
| 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate | Drug | The parturients were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL. |
|
| 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate | Drug | The parturients were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL. |
|
| Forty-eight hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Two hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Four hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Eight hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Twelve hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Twenty-four hours after caesarean delivery |
| Postoperative pain score with movement | The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain. | Forty-eight hours after caesarean delivery |
| number of rescue analgesics required | The number of rescue analgesics required within 48 h of surgery was recorded | within Forty-eight hours of surgery |
| Four hours after caesarean delivery |
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) | Eight hours after caesarean delivery |
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) | Twelve hours after caesarean delivery |
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) | Twenty-four hours after caesarean delivery |
| systolic blood pressure (SBP) | Patient's systolic blood pressure (SBP) | Forty-eight hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Two hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Four hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Eight hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Twelve hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Twenty-four hours after caesarean delivery |
| diastolic blood pressure (DBP) | Patient's diastolic blood pressure (DBP) | Forty-eight hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Two hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Four hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Eight hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Twelve hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Twenty-four hours after caesarean delivery |
| heart rate (HR) | Patient's heart rate (HR) | Forty-eight hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Two hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Four hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Eight hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Twelve hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Twenty-four hours after caesarean delivery |
| Blood oxygen saturation (SpO2) | Measurement of pulse Blood oxygen saturation (SpO2) in parturients | Forty-eight hours after caesarean delivery |
| Adverse events | Adverse events that occurred after the administration of study drugs were also recorded. | within Forty-eight hours of surgery |
| 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 |
| C000629870 | Esketamine |
| 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 |
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