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NCT Number: NCT05414006

Effect of S-ketamine in Cesarean Section Combined Anesthesia

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

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Key information

Conditions

Postoperative Pain Hyperalgesia Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

S-ketamine

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. Patient controlled analgesia pump analgesic consumption

    Time frame: 0-48 hours postoperatively

    The amount of the analgesic consumption

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Feb 24, 2023

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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