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Postoperative Analgesic Effect of Esketamine

Primary Purpose

Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor, Analgesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
2 mg morphine sulfate
0.25mg/kg esketamine
0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
0.25mg/kg of esketamine in combination with 1 mg morphine sulfate
Sponsored by
Xuanhan County People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor

Eligibility Criteria

20 Years - 32 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Qijun Ran

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

group A

group B

group C

group D

Arm Description

The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.

The parturients in group B were administered 0.25mg/kg of esketamine.

The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.

The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
number of rescue analgesics required
The number of rescue analgesics required within 48 h of surgery was recorded

Secondary Outcome Measures

systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
systolic blood pressure (SBP)
Patient's systolic blood pressure (SBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
diastolic blood pressure (DBP)
Patient's diastolic blood pressure (DBP)
heart rate (HR)
Patient's heart rate (HR)
heart rate (HR)
Patient's heart rate (HR)
heart rate (HR)
Patient's heart rate (HR)
heart rate (HR)
Patient's heart rate (HR)
heart rate (HR)
Patient's heart rate (HR)
heart rate (HR)
Patient's heart rate (HR)
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Blood oxygen saturation (SpO2)
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Adverse events
Adverse events that occurred after the administration of study drugs were also recorded.

Full Information

First Posted
October 12, 2022
Last Updated
October 13, 2022
Sponsor
Xuanhan County People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05582135
Brief Title
Postoperative Analgesic Effect of Esketamine
Official Title
Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
August 16, 2021 (Actual)
Study Completion Date
August 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanhan County People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Active Comparator
Arm Description
The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
The parturients in group B were administered 0.25mg/kg of esketamine.
Arm Title
group C
Arm Type
Active Comparator
Arm Description
The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.
Arm Title
group D
Arm Type
Active Comparator
Arm Description
The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.
Intervention Type
Drug
Intervention Name(s)
2 mg morphine sulfate
Intervention Description
The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.
Intervention Type
Drug
Intervention Name(s)
0.25mg/kg esketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.25mg/kg of esketamine in combination with 1 mg morphine sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain score at rest
Description
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.
Time Frame
Two hours after caesarean delivery
Title
Postoperative pain score at rest
Description
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.
Time Frame
Four hours after caesarean delivery
Title
Postoperative pain score at rest
Description
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.
Time Frame
Eight hours after caesarean delivery
Title
Postoperative pain score at rest
Description
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.
Time Frame
Twelve hours after caesarean delivery
Title
Postoperative pain score at rest
Description
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.
Time Frame
Twenty-four hours after caesarean delivery
Title
Postoperative pain score at rest
Description
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.
Time Frame
Forty-eight hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Two hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Four hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Eight hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Twelve hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Twenty-four hours after caesarean delivery
Title
Postoperative pain score with movement
Description
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.
Time Frame
Forty-eight hours after caesarean delivery
Title
number of rescue analgesics required
Description
The number of rescue analgesics required within 48 h of surgery was recorded
Time Frame
within Forty-eight hours of surgery
Secondary Outcome Measure Information:
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Two hours after caesarean delivery
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Four hours after caesarean delivery
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Eight hours after caesarean delivery
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Twelve hours after caesarean delivery
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Twenty-four hours after caesarean delivery
Title
systolic blood pressure (SBP)
Description
Patient's systolic blood pressure (SBP)
Time Frame
Forty-eight hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Two hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Four hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Eight hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Twelve hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Twenty-four hours after caesarean delivery
Title
diastolic blood pressure (DBP)
Description
Patient's diastolic blood pressure (DBP)
Time Frame
Forty-eight hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Two hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Four hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Eight hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Twelve hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Twenty-four hours after caesarean delivery
Title
heart rate (HR)
Description
Patient's heart rate (HR)
Time Frame
Forty-eight hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Two hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Four hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Eight hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Twelve hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Twenty-four hours after caesarean delivery
Title
Blood oxygen saturation (SpO2)
Description
Measurement of pulse Blood oxygen saturation (SpO2) in parturients
Time Frame
Forty-eight hours after caesarean delivery
Title
Adverse events
Description
Adverse events that occurred after the administration of study drugs were also recorded.
Time Frame
within Forty-eight hours of surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Qijun Ran
City
Dazhou
State/Province
Sichuan
ZIP/Postal Code
636150
Country
China

12. IPD Sharing Statement

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Postoperative Analgesic Effect of Esketamine

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