Postoperative Analgesic Effect of Esketamine

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

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 Overview

• Status: Completed
• Conditions: Analgesia; Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Dazhou, Sichuan, China, 636150
      • Qijun Ran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.	Drug: 2 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.
Active Comparator: group B; The parturients in group B were administered 0.25mg/kg of esketamine.	Drug: 0.25mg/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.
Active Comparator: group C; 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; 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.
Active Comparator: group D; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xuanhan County People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): August 16, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Morphine; Esketamine
• Other Study ID Numbers: XuanhanCo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No