Esketamine Combined With Pregabalin on CPSP in Spinal Patients.

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117917

Collaborator

(none)

150

Enrollment

Location

Arms

7.7

Anticipated Duration (Months)

19.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esketamine Pregabaline Chronic Post Operative Pain	Drug: S-ketamine and pregabalin Drug: Normal saline and placebo capsule	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital	Beijing		China	100070

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruquan Han, Professor, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT06117917

Other Study ID Numbers:

Smile202310

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023