Chronic Post Operative Pain, Oxycodone, Postoperative Complications, Pregabalin
Conditions
Brief summary
Chronic postoperative pain is one of the common perioperative complications, which seriously affects the prognosis of patients. Currently, no specific perioperative pain management strategy has been found to be effective in preventing and treating chronic postoperative pain in patients undergoing spinal surgery. At present, oxycodone has been widely recognized in different surgical populations for the control of acute postoperative pain, but its contribution to chronic postoperative pain remains unknown. Meanwhile, whether pregabalin can reduce the occurrence of chronic postoperative pain remains controversial, and whether the combination of the two drugs can control the occurrence of chronic postoperative pain in a more comprehensive way remains unknown. Therefore, we intend to conduct this randomized-controlled, factorial design study to determine the efficacy and safety of oxycodone combined with pregabalin in the treatment of chronic postoperative pain in patients undergoing spinal surgery.
Interventions
DRUGOxycodone and Pregabalin
Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1\ 7,75mg QD for POD8\ 14
DRUGOxycodone and placebo capsules
Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
DRUGPregabalin and NS
Pregabalin: 150mg preoperatively, 75mg BID for POD1\ 7,75mg QD for POD8\ 14 NS: Equal volume NS for 3 days postoperatively
DRUGplacebo capsules and NS
placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing elective spinal surgery * Ages equal to or more than 18 years old * ASA I-III * Signed informed consent
Exclusion criteria
* Previous allergic history to gabapentinoids or oxycodone; * Patients with aphasia or inability to cooperate with scales assessments; * Patients with a diagnosed history of psychiatric disorder; * Known severe insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure); * Patients treated with gabapentin/pregabalin in the last three months; * History of drug abuse; * Body Mass Index more than 35 kg/㎡; * Pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of CPSP | 3 months after surgery | The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score \>3 (0\ 10). |
Countries
China
Contacts
Primary ContactRuquan Han, M.D., Ph D.
Outcome results
None listed