Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient undergoing elective spinal surgery
Ages equal to or more than 18 years old
ASA I-III
Signed informed consent
Disqualifiers
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);
Trial design
Design model
Factorial
Treatments tested in this trial
Oxycodone and Pregabalin
DrugOxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1\~7,75mg QD for POD8\~14
Oxycodone and placebo capsules
DrugOxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
Pregabalin and NS
DrugPregabalin: 150mg preoperatively, 75mg BID for POD1\~7,75mg QD for POD8\~14 NS: Equal volume NS for 3 days postoperatively
placebo capsules and NS
Drugplacebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively
Treatment groups
264 Participants
are divided into 4 treatment groupsGroup A: Combined groupExperimental treatment 1 intervention
Group B: Oxycodone groupOther 1 intervention
Group C: Pregabalin groupOther 1 intervention
Group D: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
the incidence of CPSP
The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score \>3 (0\~10).
Time frame
3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov