Clincosm LogoSign in Get a demo

Effect of S-ketamine in Cesarean Section Combined Anesthesia

Sponsor
The Second Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05414006
Collaborator
(none)
120
Enrollment
1
Location
4
Arms
6.6
Anticipated Duration (Months)
18.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.

Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were includedAccording to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of S-ketamine in Cesarean Section Combined Anesthesia
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: E1

S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

Drug: S-ketamine
S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
Other Names:
  • Patient controlled analgesia

    		•
    Experimental: E2

    S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

    Drug: S-ketamine
    S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
    Other Names:
  • Patient controlled analgesia

    		•
    Placebo Comparator: C1

    placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

    Drug: S-ketamine
    S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
    Other Names:
  • Patient controlled analgesia

    		•
    Placebo Comparator: C2

    placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

    Drug: S-ketamine
    S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
    Other Names:
  • Patient controlled analgesia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hyperalgesia at 30 after surgery [Change from baseline to 30 minutes postoperatively]

      Pain threshold and pain tolerance in the forearm of dominant hand

    2. Hyperalgesia at 24 hours after surgery [Change from baseline to 24 hours postoperatively]

      Pain threshold and pain tolerance in the forearm of dominant hand

    Secondary Outcome Measures

    1. Pain score (NRS socre) at 0-6 hours postoperatively [From ending of the surgery to 6 hours postoperatively]

      NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

    2. Pain score (NRS socre) at 6-12 hours postoperatively [From 6 hours postoperatively to 12 hours postoperatively]

      NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

    3. Pain score (NRS socre) at 12-24 hours postoperatively [From 12 hours postoperatively to 24 hours postoperatively]

      NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful

    4. The number of patient controlled analgesia pump pressed [0-48 hours postoperatively]

      When the patients felt pain, the patient controlled analgesia pump can be pressed once

    5. Patient controlled analgesia pump analgesic consumption [0-48 hours postoperatively]

      The amount of the analgesic consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA status I-III

    • Age 20 to 45

    • 37-42 weeks gestation

    • undergo elective cesarean section with subarachnoid anesthesia

    • participate in this study and sign informed consent

    Exclusion Criteria:

    • Patients with contraindications for cesarean section

    • Patients with contraindications of combined spinal and epidural anesthesia

    • Patients with severe systemic disease

    • Alcoholism and long-term use of anti-inflammatory and analgesic drugs

    • Patients who were unable to cooperate or refused to participate in the trial

    • Patients with contraindications to esketamine and hydromorphone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University Chongqing Chongqing China 400010

    Sponsors and Collaborators

    • The Second Affiliated Hospital of Chongqing Medical University

    Investigators

    • Study Director: HUANG HE, MD, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Second Affiliated Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05414006
    Other Study ID Numbers:
    • S-ketamine and CS hyperalgesia
    First Posted:
    Jun 10, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Second Affiliated Hospital of Chongqing Medical University
    S-ketamine
    Cesarean Section
    hyperalgesia
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ketamine
    Esketamine

    Study Results

    No Results Posted as of Jul 14, 2022