Clinical trial NCT05582135: Postoperative Analgesic Effect of Esketamine
Official title: Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor
Analgesia
Lead sponsor: Xuanhan County People's Hospital
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 119
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain score at rest
timeFrame: Two hours after caesarean delivery
measure: Postoperative pain score at rest
timeFrame: Four hours after caesarean delivery
measure: Postoperative pain score at rest
timeFrame: Eight hours after caesarean delivery
measure: Postoperative pain score at rest
timeFrame: Twelve hours after caesarean delivery
measure: Postoperative pain score at rest
timeFrame: Twenty-four hours after caesarean delivery
measure: Postoperative pain score at rest
timeFrame: Forty-eight hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Two hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Four hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Eight hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Twelve hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Twenty-four hours after caesarean delivery
measure: Postoperative pain score with movement
timeFrame: Forty-eight hours after caesarean delivery
measure: number of rescue analgesics required
timeFrame: within Forty-eight hours of surgery
Secondary outcomes:
measure: systolic blood pressure (SBP)
timeFrame: Two hours after caesarean delivery
measure: systolic blood pressure (SBP)
timeFrame: Four hours after caesarean delivery
measure: systolic blood pressure (SBP)
timeFrame: Eight hours after caesarean delivery
measure: systolic blood pressure (SBP)
timeFrame: Twelve hours after caesarean delivery
measure: systolic blood pressure (SBP)
timeFrame: Twenty-four hours after caesarean delivery
measure: systolic blood pressure (SBP)
timeFrame: Forty-eight hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Two hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Four hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Eight hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Twelve hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Twenty-four hours after caesarean delivery
measure: diastolic blood pressure (DBP)
timeFrame: Forty-eight hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Two hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Four hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Eight hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Twelve hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Twenty-four hours after caesarean delivery
measure: heart rate (HR)
timeFrame: Forty-eight hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Two hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Four hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Eight hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Twelve hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Twenty-four hours after caesarean delivery
measure: Blood oxygen saturation (SpO2)
timeFrame: Forty-eight hours after caesarean delivery
measure: Adverse events
timeFrame: within Forty-eight hours of surgery
Other outcomes:
Locations:
city: Dazhou
country: China
facility: Qijun Ran
state: Sichuan
Study officials:
References: