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Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery

Not Applicable
Recruiting
Conditions
Pregabalin
Postoperative Complications
Chronic Post Operative Pain
Oxycodone
Interventions
Registration Number
NCT05795478
Lead Sponsor
Beijing Tiantan Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
264
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Combined groupOxycodone and PregabalinOxycodone+Pregabalin
Oxycodone groupOxycodone and placebo capsulesOxycodone+placebo capsules
Pregabalin groupPregabalin and NSNS+Pregabalin
Control groupplacebo capsules and NSNS+placebo capsules
Primary Outcome Measures
NameTimeMethod
the incidence of CPSP3 months after surgery

The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score \>3 (0\~10).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Beijing Tiantan Hospital

🇨🇳

Beijing, China

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