Chronic Post Operative Pain, Esketamine, Pregabaline
Conditions
Brief summary
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.
Interventions
* 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
* 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
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportion of patients with chronic postsurgical pain during 3 months after operation | 3 months postoperatively | The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score ≥ 3). |
Countries
China
Contacts
Primary ContactRuquan Han, M.D., Ph D
Outcome results
None listed