Clinical trial NCT05160493: The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.
Official title: The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Postsurgical Pain
Keywords: Esketamine
Pregabalin
Craniotomy
Chronic Postsurgical Pain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of craniotomy patients with NRS score greater than one 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D.
role: STUDY_CHAIR
References: