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Completed

NCT Number: NCT05582135

Postoperative Analgesic Effect of Esketamine

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.

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Key information

Conditions

Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–32 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Qijun Ran

Dazhou, Sichuan, 636150, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 mg morphine sulfate

Drug

The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.

0.25mg/kg esketamine

Drug

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.

0.25mg/kg of esketamine in combination with 2 mg morphine sulfate

Drug

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.

0.25mg/kg of esketamine in combination with 1 mg morphine sulfate

Drug

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 outcomes

  1. Postoperative pain score at rest

    Time frame: Two 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.

  2. Postoperative pain score at rest

    Time frame: Four 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.

  3. Postoperative pain score at rest

    Time frame: 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.

  4. Postoperative pain score at rest

    Time frame: Twelve 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.

  5. Postoperative pain score at rest

    Time frame: Twenty-four 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.

  6. 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.

  7. Postoperative pain score with movement

    Time frame: Two 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.

  8. Postoperative pain score with movement

    Time frame: Four 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.

  9. Postoperative pain score with movement

    Time frame: 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.

  10. Postoperative pain score with movement

    Time frame: Twelve 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.

  11. Postoperative pain score with movement

    Time frame: Twenty-four 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.

  12. 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.

  13. 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

  1. systolic blood pressure (SBP)

    Time frame: Two hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  2. systolic blood pressure (SBP)

    Time frame: Four hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  3. systolic blood pressure (SBP)

    Time frame: Eight hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  4. systolic blood pressure (SBP)

    Time frame: Twelve hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  5. systolic blood pressure (SBP)

    Time frame: Twenty-four hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  6. systolic blood pressure (SBP)

    Time frame: Forty-eight hours after caesarean delivery

    Patient's systolic blood pressure (SBP)

  7. diastolic blood pressure (DBP)

    Time frame: Two hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  8. diastolic blood pressure (DBP)

    Time frame: Four hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  9. diastolic blood pressure (DBP)

    Time frame: Eight hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  10. diastolic blood pressure (DBP)

    Time frame: Twelve hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  11. diastolic blood pressure (DBP)

    Time frame: Twenty-four hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  12. diastolic blood pressure (DBP)

    Time frame: Forty-eight hours after caesarean delivery

    Patient's diastolic blood pressure (DBP)

  13. heart rate (HR)

    Time frame: Two hours after caesarean delivery

    Patient's heart rate (HR)

  14. heart rate (HR)

    Time frame: Four hours after caesarean delivery

    Patient's heart rate (HR)

  15. heart rate (HR)

    Time frame: Eight hours after caesarean delivery

    Patient's heart rate (HR)

  16. heart rate (HR)

    Time frame: Twelve hours after caesarean delivery

    Patient's heart rate (HR)

  17. heart rate (HR)

    Time frame: Twenty-four hours after caesarean delivery

    Patient's heart rate (HR)

  18. heart rate (HR)

    Time frame: Forty-eight hours after caesarean delivery

    Patient's heart rate (HR)

  19. Blood oxygen saturation (SpO2)

    Time frame: Two hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  20. Blood oxygen saturation (SpO2)

    Time frame: Four hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  21. Blood oxygen saturation (SpO2)

    Time frame: Eight hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  22. Blood oxygen saturation (SpO2)

    Time frame: Twelve hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  23. Blood oxygen saturation (SpO2)

    Time frame: Twenty-four hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  24. Blood oxygen saturation (SpO2)

    Time frame: Forty-eight hours after caesarean delivery

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

  25. Adverse events

    Time frame: within Forty-eight hours of surgery

    Adverse events that occurred after the administration of study drugs were also recorded.

Sponsors and collaborators

Lead sponsor

Xuanhan County People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 17, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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