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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: S-ketamine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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: Group 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: 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	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: Group 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patient controlled analgesia pump pressed	When the patients felt pain, the patient controlled analgesia pump can be pressed once	0-48 hours postoperatively
Patient controlled analgesia pump analgesic consumption	The amount of the analgesic consumption	0-48 hours postoperatively
Pressure pain threshold at 30min after surgery	Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2	Change from baseline to 30 minutes postoperatively
Pressure pain threshold at 24 hours after surgery	Pressure pain threshold was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2	Change from baseline to 30 min postoperatively
Pressure pain tolerance at 30min hours after surgery	Pressure pain tolerance was measured using pressure manometer in the forearm of dominant hand reported by kg/cm2	Change from baseline to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 5, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: S-ketamine; Cesarean Section; hyperalgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Psychotropic Drugs; Antidepressive Agents; Ketamine; Esketamine
• Other Study ID Numbers: S-ketamine and CS hyperalgesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email
• IPD Sharing Time Frame: Within five years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No