Clinical trial
Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery.
Name
Smile202310
Description
Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.
Trial arms
Trial start
2023-11-10
Estimated PCD
2024-05-31
Trial end
2024-06-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
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 7 days(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
Arms:
S-ketamine and pregabalin
Normal saline and placebo capsule
* Drug: Placebo capsules
* Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
* Drug: Normal saline
* 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours
Arms:
Normal saline and placebo capsule
Size
150
Primary endpoint
the proportion of patients with chronic postsurgical pain during 3 months after operation
3 months postoperatively
Eligibility criteria
Inclusion Criteria:
* Patient undergoing elective primary spinal tumor surgery;
* Ages between 18 and 65 years old;
* American Society of Anaesthesiology (ASA) status I-III;
* Signed informed consent.
Exclusion Criteria:
* Previous adverse reaction to ketamine, s-ketamine or pregabalin;
* Patients with a diagnosed history of severe chronic pain;
* Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
* Patients with aphasia or inability to cooperate with the pain assessments;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with a diagnosed history of psychiatric disorder;
* Patients treated with gabapentin/pregabalin in the last three months;
* Drug abuse;
* Body mass index (BMI) \> 35 kg/m2 ;
* Pregnancy or lactation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
2 products
3 indications
Organization
Beijing Tiantan HospitalProduct
S-ketamineIndication
EsketamineIndication
PregabalinIndication
Chronic Postoperative PainProduct
Normal saline