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

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Capital Medical University

Status and phase

Completed
Phase 3
Phase 2

Conditions

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

Treatments

Drug: Normal saline and placebo capsule
Drug: S-ketamine and pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT05096468
Z19110000661906703

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 2 patient groups, including a placebo group

S-ketamine and pregabalin
Experimental group
Treatment:
Drug: S-ketamine and pregabalin
Normal saline and placebo capsule
Placebo Comparator group
Treatment:
Drug: Normal saline and placebo capsule

Trial contacts and locations

1

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Central trial contact

Ruquan Han, M.D., Ph D.

Data sourced from clinicaltrials.gov

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