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

Chronic Postsurgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160493
• Other study ID #: 20211206
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 20, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2022
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D., Ph D.
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Postsurgical Pain
• Pain, Postoperative

Intervention

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
• Normal saline and placebo capsule
Normal saline and placebo capsule

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Fengtai Dist.	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of craniotomy patients with NRS score greater than one 3 months after surgery		3 months after surgery