Effect of S-ketamine in Cesarean Section Combined Anesthesia

Postoperative Pain Clinical Trial

Official title:

Effect of S-ketamine in Cesarean Section Combined Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05414006
• Other study ID #: S-ketamine and CS hyperalgesia
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: September 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 5, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• S-ketamine
S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively

Locations

Country	Name	City	State
China	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Patient controlled analgesia pump analgesic consumption	The amount of the analgesic consumption	0-48 hours postoperatively
Secondary	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
Secondary	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
Secondary	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