Analgesia, Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor
Conditions
Brief summary
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.
Interventions
DRUG2 mg morphine sulfate
The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.
DRUG0.25mg/kg esketamine
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.
DRUG0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
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.
DRUG0.25mg/kg of esketamine in combination with 1 mg morphine sulfate
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.
Sponsors
Xuanhan County People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 32 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at rest | Two hours after caesarean delivery | 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. |
| Postoperative pain score with movement | Two hours after caesarean delivery | 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. |
| number of rescue analgesics required | within Forty-eight hours of surgery | The number of rescue analgesics required within 48 h of surgery was recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygen saturation (SpO2) | Two hours after caesarean delivery | Measurement of pulse Blood oxygen saturation (SpO2) in parturients |
| systolic blood pressure (SBP) | Two hours after caesarean delivery | Patient's systolic blood pressure (SBP) |
| Adverse events | within Forty-eight hours of surgery | Adverse events that occurred after the administration of study drugs were also recorded. |
| diastolic blood pressure (DBP) | Two hours after caesarean delivery | Patient's diastolic blood pressure (DBP) |
| heart rate (HR) | Two hours after caesarean delivery | Patient's heart rate (HR) |
Countries
China
Outcome results
None listed