Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

NCT ID: NCT06117917

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2024-06-30

Brief 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.

Conditions

Esketamine; Pregabaline; Chronic Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

S-ketamine and pregabalin

Group Type: EXPERIMENTAL

S-ketamine and pregabalin

Intervention Type: DRUG

• 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

Group Type: PLACEBO_COMPARATOR

Normal saline and placebo capsule

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruquan Han, M.D., Ph D

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, , China

Countries

China

Central Contacts

Ruquan Han, M.D., Ph D

Role: CONTACT

ruquan.han@ccmu.edu.cn

8610-59976660

Facility Contacts

Ruquan Han, M.D., Ph D.

Role: primary

ruquan.han@ccmu.edu.cn

8610-59976660

Other Identifiers

Smile202310

Identifier Type: -

Identifier Source: org_study_id