Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Post Operative Pain; Esketamine; Pregabaline
• Intervention / Treatment: Drug: S-ketamine and pregabalin; Drug: Normal saline and placebo capsule

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D., Ph D; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital
    • Contact: Ruquan Han, M.D., Ph D.; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-ketamine and pregabalin	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
Placebo Comparator: Normal saline and placebo capsule	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Ruquan Han, M.D., Ph D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Antidepressive Agents; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Ketamine; Pregabalin; Esketamine
• Other Study ID Numbers: Smile202310

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No