Postoperative Analgesic Effect of Esketamine

Study Overview
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Brief Summary
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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.

Official Title
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Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study

Conditions
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Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor, Analgesia

Intervention / Treatment
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* Drug: 2 mg morphine sulfate
* Drug: 0.25mg/kg esketamine
* Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
* Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nulliparous parturients who scheduled for elective caesarean delivery under spinal-epidural anaesthesia; parturients who had requested postoperative analgesia; parturients aged between 20-35 years old; parturients who had a full-term pregnancy; parturients who were identified as having a singleton pregnancy; and parturients who were categorised as having an American Society of Anaesthesiologists (ASA) physical status Exclusion Criteria: parturients with severe internal, surgical or obstetric comorbidities (including spinal deformities, hypertension, placental abruption, cholestasis in pregnancy, asthma, heart disease and abnormal coagulation parameters) parturients with a known allergy to the drugs used in this study parturients with severe mental illness who could not comply with doctors' instructions parturients with chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group A<br>The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter. | Drug: 2 mg morphine sulfate<br>* The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.<br>|
| Active Comparator: group B<br>The parturients in group B were administered 0.25mg/kg of esketamine. | Drug: 0.25mg/kg esketamine<br>* 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.<br>|
| Active Comparator: group C<br>The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate. | Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate<br>* 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.<br>|
| Active Comparator: group D<br>The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate. | Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |