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

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.

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Key information

Conditions

Esketamine Acute Postoperative Pain Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Neurosurgical Procedures Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative Complication Postoperative Complications Pregabalin Signs and Symptoms Spinal Cord Diseases Spinal Cord Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beijing Tiantan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-ketamine and pregabalin

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

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

Primary outcomes

the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 27, 2021
Registry last updated: Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed