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

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ClinicalTrials.gov Identifier: NCT05096468
Recruitment Status : Not yet recruiting
First Posted : October 27, 2021
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Ruquan Han, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE October 15, 2021
First Posted Date  ICMJE October 27, 2021
Last Update Posted Date December 10, 2021
Estimated Study Start Date  ICMJE November 30, 2021
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2021)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2021)
the VAS Score at 48h after operation [ Time Frame: 48 hours after operation ]
the VAS score (Visual Analogue Scale : 0-100mm)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Official Title  ICMJE Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Esketamine
  • Pregabalin
  • Acute Postoperative Pain
  • Neurosurgical Procedures
  • Perioperative Complication
  • Spinal Cord Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: S-ketamine and pregabalin
    Intervention: Drug: S-ketamine and pregabalin
  • Placebo Comparator: Normal saline and placebo capsule
    Intervention: Drug: Normal saline and placebo capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2021)
94
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date August 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ruquan Han, M.D., Ph D. 8610-59976660 ruquan.han@ccmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05096468
Other Study ID Numbers  ICMJE Z19110000661906703
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ruquan Han, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ruquan Han, M.D., Ph D. Beijing Tiantan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP