NCT05096468

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esketamine
• Pregabalin
• Acute Postoperative Pain
• Neurosurgical Procedures
• Perioperative Complication
• Spinal Cord Neoplasms

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-06-28
• Completion: 2022-10-15
• First posted: 2021-10-27
• Last updated: 2023-07-06

Locations

1 site across 1 country: China