The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    246
  • sponsor
    Beijing Tiantan Hospital
Updated on 24 May 2022

Summary

Chronic postsurgical pain (CPSP), which is one of the most common and serious long term complication of surgery,occurs in approximately 10% of patients after a surgical procedure. Craniotomy was previously considered to have less chronic pain than other surgical procedures. Contrarily, studies have reported incidences of chronic headache varies for type of craniotomy, ranging from 23% to 34% at three months and 12% to 16% at one year after surgery. In addition,CPSP is associated with adverse events, including postoperative morbidity, increased health-care costs, significant impaired on quality of life, prolonged opioid use. Optimising perioperative pain management should reduce the incidence of CPSP; The non-opioid analgesics, such as ketamine and pregabalin, have also been used as components of multimodal anesthetic protocols. Postoperative pain scores and opioid use are significantly reduced in thoracotomy surgical patients given ketamine and pregabalin compared to control groups.however, there is currently a lack of evidence regarding which therapeutic options are most effective in reducing the incidence of chronic post-craniotomy headache. The investigators hypothesis is that sketamine combined with pregabalin reduces significantly chronic postoperative pain after craniotomy and improves patient outcome.

Details
Condition Chronic Postsurgical Pain
Treatment S-ketamine and pregabalin, Normal saline and placebo capsule
Clinical Study IdentifierNCT05160493
SponsorBeijing Tiantan Hospital
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults, age ≥18 years, male or female
American Society of Anaesthesiology (ASA) status I-III
Patients undergoing elective craniotomy

Exclusion Criteria

Patients unable to complete scale assessment
Pregnant or lactating women
Patients with preoperative chronic pain syndrome
Patients with previous craniotomy history
Patients with a history of mental illness who are receiving medication
Patients with liver and kidney dysfunction
Patients have taken pain medication within two weeks
Patients with history of adverse reactions to pregabalin, ketamine and esticketamine
Patients with history of drug abuse
BMI>35.0 kg · m - 2
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