Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05096468

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.

Condition or Disease	Intervention/Treatment	Phase
Esketamine Pregabalin Acute Postoperative Pain Neurosurgical Procedures Perioperative Complication Spinal Cord Neoplasms	Drug: S-ketamine and pregabalin Drug: Normal saline and placebo capsule	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 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 Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

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 acute moderate-to-severe postsurgical pain during 48h after operation [48 hours after operation]
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient undergoing elective spinal cord neoplasms resection;
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.