Postoperative Analgesic Effect of Esketamine

Not Applicable

Completed

• Conditions: Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor; Analgesia
• Interventions: 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; Drug: 0.25mg/kg esketamine; Drug: 2 mg morphine sulfate

• Registration Number: NCT05582135
• Lead Sponsor: Xuanhan County People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-05
• Primary Completion: 2021-08-16
• Study Completion: 2021-08-16
• Status Verified: 2022-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Study First Posted: 2022-10-17
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	0.25mg/kg of esketamine in combination with 2 mg morphine sulfate	The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.
group D	0.25mg/kg of esketamine in combination with 1 mg morphine sulfate	The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.
group B	0.25mg/kg esketamine	The parturients in group B were administered 0.25mg/kg of esketamine.
group A	2 mg morphine sulfate	The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.

Primary Outcome Measures

Name	Time	Method
Postoperative pain score at rest	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	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	within Forty-eight hours of surgery	The number of rescue analgesics required within 48 h of surgery was recorded

Secondary Outcome Measures

Name	Time	Method
heart rate (HR)	Forty-eight hours after caesarean delivery	Patient's heart rate (HR)
Blood oxygen saturation (SpO2)	Forty-eight hours after caesarean delivery	Measurement of pulse Blood oxygen saturation (SpO2) in parturients
systolic blood pressure (SBP)	Forty-eight hours after caesarean delivery	Patient's systolic blood pressure (SBP)
diastolic blood pressure (DBP)	Forty-eight hours after caesarean delivery	Patient's diastolic blood pressure (DBP)
Adverse events	within Forty-eight hours of surgery	Adverse events that occurred after the administration of study drugs were also recorded.

Trial Locations

Locations (1)

Qijun Ran; 🇨🇳 Dazhou, Sichuan, China