Effect of S-ketamine in Cesarean Section Combined Anesthesia

NCT05414006 | Completed Phase 4 DMC

• 1 other identifier: S-ketamine and CS hyperalgesia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

S-ketamine; Cesarean Section; hyperalgesia

Outcome Measures

Primary Outcomes (4)

• Maximum pain score (NRS socre) at 0-24 hours postoperatively

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

  From ending of the surgery to 24 hours postoperatively

• Pain score (NRS socre) at 0-6 hours postoperatively

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

  From ending of the surgery to 6 hours postoperatively

• Pain score (NRS socre) at 6-12 hours postoperatively

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

  From 6 hours postoperatively to 12 hours postoperatively

• Pain score (NRS socre) at 12-24 hours postoperatively

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

  From 12 hours postoperatively to 24 hours postoperatively

Secondary Outcomes (5)

• The number of patient controlled analgesia pump pressed

  0-48 hours postoperatively

• Patient controlled analgesia pump analgesic consumption

  0-48 hours postoperatively

• Pressure pain threshold at 30min after surgery

  Change from baseline to 30 minutes postoperatively

• Pressure pain threshold at 24 hours after surgery

  Change from baseline to 30 min postoperatively

• Pressure pain tolerance at 30min hours after surgery

  Change from baseline to 24 hours postoperatively

Study Arms (4)

Group E1

EXPERIMENTAL

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

Group E2

EXPERIMENTAL

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

Drug: S-ketamine

Group C1

PLACEBO COMPARATOR

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

Group C2

PLACEBO COMPARATOR

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

Drug: S-ketamine

Interventions

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

Also known as: Patient controlled analgesia

Group C1; Group C2; Group E1; Group E2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA status I-III
• Age 20 to 45
• weeks gestation
• undergo elective cesarean section with subarachnoid anesthesia
• participate in this study and sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• Zhang J, Sun D, Wang J, Chen J, Chen Y, Shu B, Huang H, Duan G. Exploring the Analgesic Efficacy and mechanisms of low-dose esketamine in pregnant women undergoing cesarean section: A randomized controlled trial. Heliyon. 2024 Jul 30;10(15):e35434. doi: 10.1016/j.heliyon.2024.e35434. eCollection 2024 Aug 15.

  PMID: 39170110 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia

Interventions

Esketamine; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• HUANG HE, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 10, 2022
• Study Start: June 14, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 5, 2022
• Last Updated: February 24, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within five years

Locations

CN (1)