Effect of S-ketamine in Cesarean Section Combined Anesthesia

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: S-ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05414006

S-ketamine and CS hyperalgesia

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Group E1

Experimental group

Description:

S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

Treatment:

Drug: S-ketamine

Group E2

Experimental group

Description:

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

Treatment:

Drug: S-ketamine

Group C1

Placebo Comparator group

Description:

placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml

Treatment:

Drug: S-ketamine

Group C2

Placebo Comparator group

Description:

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

Treatment:

Drug: S-ketamine