Effect of S-ketamine in Cesarean Section Combined Anesthesia

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: S-ketamine

• Registration Number: NCT05414006
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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 available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Study Start: 2022-06-14
• Primary Completion: 2022-08-31
• Status Verified: 2022-09
• Study Completion: 2022-09-05
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group C2	S-ketamine	placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml
Group C1	S-ketamine	placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml
Group E1	S-ketamine	S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml
Group E2	S-ketamine	S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml

Primary Outcome Measures

Name	Time	Method
Maximum pain score (NRS socre) at 0-24 hours postoperatively	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	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 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
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

Secondary Outcome Measures

Name	Time	Method
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
Pressure pain threshold at 30min after surgery	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
Patient controlled analgesia pump analgesic consumption	0-48 hours postoperatively	The amount of the analgesic consumption
Pressure pain threshold at 24 hours after surgery	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	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

Trial Locations

Locations (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China