Clinical trial NCT05414006: Effect of S-ketamine in Cesarean Section Combined Anesthesia
Official title: Effect of S-ketamine in Cesarean Section Combined Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: S-ketamine
Cesarean Section
hyperalgesia
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum pain score (NRS socre) at 0-24 hours postoperatively
timeFrame: From ending of the surgery to 24 hours postoperatively
measure: Pain score (NRS socre) at 0-6 hours postoperatively
timeFrame: From ending of the surgery to 6 hours postoperatively
measure: Pain score (NRS socre) at 6-12 hours postoperatively
timeFrame: From 6 hours postoperatively to 12 hours postoperatively
measure: Pain score (NRS socre) at 12-24 hours postoperatively
timeFrame: From 12 hours postoperatively to 24 hours postoperatively
Secondary outcomes:
measure: The number of patient controlled analgesia pump pressed
timeFrame: 0-48 hours postoperatively
measure: Patient controlled analgesia pump analgesic consumption
timeFrame: 0-48 hours postoperatively
measure: Pressure pain threshold at 30min after surgery
timeFrame: Change from baseline to 30 minutes postoperatively
measure: Pressure pain threshold at 24 hours after surgery
timeFrame: Change from baseline to 30 min postoperatively
measure: Pressure pain tolerance at 30min hours after surgery
timeFrame: Change from baseline to 24 hours postoperatively
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
name: HUANG HE, MD
role: STUDY_DIRECTOR
References: