Effect of S-ketamine in Cesarean Section Combined Anesthesia

Study Overview
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Brief Summary
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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

Official Title
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Effect of S-ketamine in Cesarean Section Combined Anesthesia

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: S-ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E1<br>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<br>* S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively<br>* Other names: Patient controlled analgesia;|
| Experimental: Group E2<br>S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml | Drug: S-ketamine<br>* S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively<br>* Other names: Patient controlled analgesia;|
| Placebo Comparator: Group C1<br>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<br>* S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively<br>* Other names: Patient controlled analgesia;|
| Placebo Comparator: Group C2<br>placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml | Drug: S-ketamine<br>* S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively<br>* Other names: Patient controlled analgesia;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-ketamine, Cesarean Section, hyperalgesia