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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Chronic Post Operative Pain; Pregabalin; Oxycodone
• Intervention / Treatment: Drug: Oxycodone and Pregabalin; Drug: Oxycodone and placebo capsules; Drug: Pregabalin and NS; Drug: placebo capsules and NS

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D., Ph D.; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital
    • Contact: Ruquan Han, M.D., Ph.D; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined group; Oxycodone+Pregabalin	Drug: Oxycodone and Pregabalin; Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1~7,75mg QD for POD8~14
Other: Oxycodone group; Oxycodone+placebo capsules	Drug: Oxycodone and placebo capsules; Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
Other: Pregabalin group; NS+Pregabalin	Drug: Pregabalin and NS; Pregabalin: 150mg preoperatively, 75mg BID for POD1~7,75mg QD for POD8~14 NS: Equal volume NS for 3 days postoperatively
Placebo Comparator: Control group; NS+placebo capsules	Drug: placebo capsules and NS; placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of CPSP	The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).	3 months after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Ruquan Han, M.D., Ph D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin; Oxycodone
• Other Study ID Numbers: sunQKT6660

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No