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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06117917
Other study ID # Smile202310
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 10, 2023
Est. completion date June 30, 2024

Study information

Verified date October 2023
Source Beijing Tiantan Hospital
Contact Ruquan Han, M.D., Ph D
Phone 8610-59976660
Email ruquan.han@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patient undergoing elective primary spinal tumor surgery; - Ages between 18 and 65 years old; - American Society of Anaesthesiology (ASA) status I-III; - Signed informed consent. Exclusion Criteria: - Previous adverse reaction to ketamine, s-ketamine or pregabalin; - Patients with a diagnosed history of severe chronic pain; - Patients with long-term analgesic treatment(gabapentin/opioids/ketamine); - Patients with aphasia or inability to cooperate with the pain assessments; - Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); - Patients with a diagnosed history of psychiatric disorder; - Patients treated with gabapentin/pregabalin in the last three months; - Drug abuse; - Body mass index (BMI) > 35 kg/m2 ; - Pregnancy or lactation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
S-ketamine and pregabalin
Drug: Pregabalin 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14) Drug: S-ketamine infusion 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h
Normal saline and placebo capsule
Drug: Placebo capsules Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days Drug: Normal saline 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours

Locations

Country Name City State
China Beijing Tiantan Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the proportion of patients with chronic postsurgical pain during 3 months after operation The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score = 3). 3 months postoperatively
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