Postoperative Pain
Conditions
Keywords
S-ketamine, Cesarean Section, hyperalgesia
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
Interventions
DRUGS-ketamine
S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| Patient controlled analgesia pump analgesic consumption | 0-48 hours postoperatively | The amount of the analgesic consumption |
| 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 |
| 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 |
Countries
China
Outcome results
None listed