Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

Esketamine Clinical Trial

Official title:

Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117917
• Other study ID #: Smile202310
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Esketamine
• Pain, Postoperative

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