Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

Phase 2

Not yet recruiting

• Conditions: Esketamine; Chronic Post Operative Pain; Pregabaline
• Interventions: Drug: S-ketamine and pregabalin; Drug: Normal saline and placebo capsule

• Registration Number: NCT06117917
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Study Start: 2023-11-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-ketamine and pregabalin	S-ketamine and pregabalin	-
Normal saline and placebo capsule	Normal saline and placebo capsule	-

Primary Outcome Measures

Name	Time	Method
the proportion of patients with chronic postsurgical pain during 3 months after operation	3 months postoperatively	The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score ≥ 3).

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China