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

Perioperative Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096468
• Other study ID #: Z19110000661906703
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: July 2023
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 15, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Esketamine
• Neoplasms
• Pain, Postoperative
• Perioperative Complication
• Pregabalin
• Spinal Cord Neoplasms
• Spinal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with acute moderate-to-severe postsurgical pain during 48h 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).	48 hours after operation