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

Ketamine

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.

Intervention / Treatment

  • 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

Condition or Disease

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

Phase

  • Phase 2
  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 90 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2021 ACTUAL
    Primary Completion: Jun 28, 2022 ACTUAL
    Completion Date: Oct 15, 2022 ACTUAL
    Study First Posted: Oct 27, 2021 ACTUAL
    Last Updated: Jul 04, 2023

    Sponsors / Collaborators

    Lead Sponsor: Beijing Tiantan Hospital
    Responsible Party: N/A

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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).

    More Details

    NCT Number: NCT05096468
    Other IDs: Z19110000661906703
    Study URL: https://clinicaltrials.gov/study/NCT05096468
    Last updated: Sep 29, 2023