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NCT Number: NCT05795478

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

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.

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Key information

Conditions

Chronic Post Operative Pain Neurologic Manifestations Oxycodone Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pregabalin Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, 100070, China

Location status: Recruiting

Location contact

Ruquan Han, M.D., Ph.D

CONTACT

[email protected]

8610-59976660

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxycodone and Pregabalin

Drug

Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1~7,75mg QD for POD8~14

Oxycodone and placebo capsules

Drug

Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point

Pregabalin and NS

Drug

Pregabalin: 150mg preoperatively, 75mg BID for POD1~7,75mg QD for POD8~14 NS: Equal volume NS for 3 days postoperatively

placebo capsules and NS

Drug

placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively

Primary outcomes

  1. the incidence of CPSP

    Time frame: 3 months after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, M.D., Ph D.

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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