The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.
CompletedPhase 2, Phase 3NCT05160493
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.
- Conditions
- Interventions
- Drug: S-ketamine and pregabalin
- Drug: Normal saline and placebo capsule
- Sponsor
- Beijing Tiantan Hospital
- Start date
- 2021-12-20
- Primary completion
- 2023-12-11
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05160493