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Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed LaborNCT05582135

Postoperative Analgesic Effect of Esketamine

A study testing 2 mg morphine sulfate, 0.25mg/kg esketamine and 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate in people with Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor and Analgesia, run by Xuanhan County People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 32 years, women only
What is being tested?
2 mg morphine sulfate, 0.25mg/kg esketamine and 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteChina
Study dates
5 May 2021to 16 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 32 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Qijun Ran

    Dazhou, Sichuan, 636150

Other trials in China

About this study

Official title: 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.

Being tested
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
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 mg morphine sulfateDrug

    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 esketamineDrug

    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 sulfateDrug

    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 sulfateDrug

    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.

Study groups in NCT05582135
Study groupRoleWhat they receive
group AActive comparatorThe parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.
Receives: Drug: 2 mg morphine sulfate
group BActive comparatorThe parturients in group B were administered 0.25mg/kg of esketamine.
Receives: Drug: 0.25mg/kg esketamine
group CActive comparatorThe parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.
Receives: Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate
group DActive comparatorThe parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.
Receives: Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two hours after caesarean delivery

  2. 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.

    Measured: Four hours after caesarean delivery

  3. 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.

    Measured: Eight hours after caesarean delivery

  4. 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.

    Measured: Twelve hours after caesarean delivery

  5. 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.

    Measured: Twenty-four hours after caesarean delivery

  6. 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.

    Measured: Forty-eight hours after caesarean delivery

  7. 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.

    Measured: Two hours after caesarean delivery

  8. 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.

    Measured: Four hours after caesarean delivery

  9. 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.

    Measured: Eight hours after caesarean delivery

  10. 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.

    Measured: Twelve hours after caesarean delivery

  11. 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.

    Measured: Twenty-four hours after caesarean delivery

  12. 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.

    Measured: Forty-eight hours after caesarean delivery

  13. number of rescue analgesics required

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

    Measured: within Forty-eight hours of surgery

Secondary outcomes (25)
  1. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Two hours after caesarean delivery

  2. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Four hours after caesarean delivery

  3. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Eight hours after caesarean delivery

  4. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Twelve hours after caesarean delivery

  5. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Twenty-four hours after caesarean delivery

  6. systolic blood pressure (SBP)

    Patient's systolic blood pressure (SBP)

    Measured: Forty-eight hours after caesarean delivery

  7. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Two hours after caesarean delivery

  8. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Four hours after caesarean delivery

  9. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Eight hours after caesarean delivery

  10. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Twelve hours after caesarean delivery

  11. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Twenty-four hours after caesarean delivery

  12. diastolic blood pressure (DBP)

    Patient's diastolic blood pressure (DBP)

    Measured: Forty-eight hours after caesarean delivery

  13. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Two hours after caesarean delivery

  14. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Four hours after caesarean delivery

  15. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Eight hours after caesarean delivery

  16. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Twelve hours after caesarean delivery

  17. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Twenty-four hours after caesarean delivery

  18. heart rate (HR)

    Patient's heart rate (HR)

    Measured: Forty-eight hours after caesarean delivery

  19. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Two hours after caesarean delivery

  20. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Four hours after caesarean delivery

  21. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Eight hours after caesarean delivery

  22. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Twelve hours after caesarean delivery

  23. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Twenty-four hours after caesarean delivery

  24. Blood oxygen saturation (SpO2)

    Measurement of pulse Blood oxygen saturation (SpO2) in parturients

    Measured: Forty-eight hours after caesarean delivery

  25. Adverse events

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

    Measured: within Forty-eight hours of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start5 May 2021
  3. Primary completion16 Aug 2021
  4. Study completion16 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05582135
Sponsor's protocol ID
XuanhanCo
Status last verified
Oct 2022
First submitted
12 Oct 2022
Last updated
17 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 2 mg morphine sulfate, 0.25mg/kg esketamine and 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate in people with Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor and Analgesia, run by Xuanhan County People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain score at rest (time frame: Two hours after caesarean delivery). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.

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