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Effect of S-ketamine in Cesarean Section Combined Anesthesia

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ClinicalTrials.gov Identifier: NCT05414006
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
The Second Affiliated Hospital of Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE June 1, 2022
First Posted Date  ICMJE June 10, 2022
Last Update Posted Date September 9, 2022
Actual Study Start Date  ICMJE June 14, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2022)
  • Maximum pain score (NRS socre) at 0-24 hours postoperatively [ Time Frame: From ending of the surgery 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
  • Pain score (NRS socre) at 0-6 hours postoperatively [ Time Frame: 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
  • Pain score (NRS socre) at 6-12 hours postoperatively [ Time Frame: 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
  • Pain score (NRS socre) at 12-24 hours postoperatively [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
  • Hyperalgesia at 30 after surgery [ Time Frame: Change from baseline to 30 minutes postoperatively ]
    Pain threshold and pain tolerance in the forearm of dominant hand
  • Hyperalgesia at 24 hours after surgery [ Time Frame: Change from baseline to 24 hours postoperatively ]
    Pain threshold and pain tolerance in the forearm of dominant hand
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2022)
  • The number of patient controlled analgesia pump pressed [ Time Frame: 0-48 hours postoperatively ]
    When the patients felt pain, the patient controlled analgesia pump can be pressed once
  • Patient controlled analgesia pump analgesic consumption [ Time Frame: 0-48 hours postoperatively ]
    The amount of the analgesic consumption
  • Pressure pain threshold at 30min after surgery [ Time Frame: Change from baseline to 30 minutes postoperatively ]
    Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
  • Pressure pain threshold at 24 hours after surgery [ Time Frame: Change from baseline to 30 min postoperatively ]
    Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
  • Pressure pain tolerance at 30min hours after surgery [ Time Frame: Change from baseline to 24 hours postoperatively ]
    Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
  • Pain score (NRS socre) at 0-6 hours postoperatively [ Time Frame: 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
  • Pain score (NRS socre) at 6-12 hours postoperatively [ Time Frame: 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
  • Pain score (NRS socre) at 12-24 hours postoperatively [ Time Frame: 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
  • The number of patient controlled analgesia pump pressed [ Time Frame: 0-48 hours postoperatively ]
    When the patients felt pain, the patient controlled analgesia pump can be pressed once
  • Patient controlled analgesia pump analgesic consumption [ Time Frame: 0-48 hours postoperatively ]
    The amount of the analgesic consumption
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of S-ketamine in Cesarean Section Combined Anesthesia
Official Title  ICMJE Effect of S-ketamine in Cesarean Section Combined Anesthesia
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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 included
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE 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 Name: Patient controlled analgesia
Study Arms  ICMJE
  • Experimental: Group 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
    Intervention: Drug: S-ketamine
  • Experimental: Group E2
    S-ketamine was administered intravenously after delivery,patient controlled intravenous analgesia(PCIA) was administered postoperatively PCIA formula:(100μg/ml hydromorphone) 100ml
    Intervention: Drug: S-ketamine
  • Placebo Comparator: Group C1
    placebo was administered intravenously after delivery,patient controlled epidural analgesia(PCEA) was administered postoperatively PCEA formula:(10μg/ml hydromorphone+0.11% ropivacaine) 200ml
    Intervention: Drug: S-ketamine
  • Placebo Comparator: Group C2
    placebo was administered intravenously after delivery,patient controlled intravenous analgesia(PCIA) was administered postoperatively PCIA formula:(100μg/ml hydromorphone) 100ml
    Intervention: Drug: S-ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2022)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: HUANG HE, MD (+86)13708385559 huanghe@cqmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05414006
Other Study ID Numbers  ICMJE S-ketamine and CS hyperalgesia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Within five years
Current Responsible Party The Second Affiliated Hospital of Chongqing Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Second Affiliated Hospital of Chongqing Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: HUANG HE, MD Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
PRS Account The Second Affiliated Hospital of Chongqing Medical University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP