NCT05160493

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Postsurgical Pain

Interventions

Type	Name	Description
DRUG	S-ketamine and pregabalin	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 7days(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	Normal saline and placebo capsule

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-12-11
• Completion: 2024-06-20
• First posted: 2021-12-16
• Last updated: 2024-08-01

Locations

1 site across 1 country: China