Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Xuanhan County People's Hospital
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Postoperative pain score at rest
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 32 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
group D
The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.
Intervention: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate (Drug)
group A
The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.
Intervention: 2 mg morphine sulfate (Drug)
group B
The parturients in group B were administered 0.25mg/kg of esketamine.
Intervention: 0.25mg/kg esketamine (Drug)
group C
The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.
Intervention: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate (Drug)
Outcomes
Primary Outcomes
Postoperative pain score at rest
Time Frame: Forty-eight 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
Time Frame: Forty-eight 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
Time Frame: within Forty-eight hours of surgery
The number of rescue analgesics required within 48 h of surgery was recorded
Secondary Outcomes
- heart rate (HR)(Forty-eight hours after caesarean delivery)
- Blood oxygen saturation (SpO2)(Forty-eight hours after caesarean delivery)
- systolic blood pressure (SBP)(Forty-eight hours after caesarean delivery)
- diastolic blood pressure (DBP)(Forty-eight hours after caesarean delivery)
- Adverse events(within Forty-eight hours of surgery)