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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Group E2 | Experimental | S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml |
|
| 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 |
|
| Group C2 | Placebo Comparator | placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HUANG HE, MD | Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39170110 | Derived | 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. |
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The individual participant data for this study is available from the sponsor on reasonable request through email
Within five years
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
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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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |