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

• Sponsor: Beijing Tiantan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05795478
• Collaborator: (none)
• Enrollment: 264
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 20.6
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Post Operative Pain; Oxycodone; Pregabalin; Postoperative Complications	Drug: Oxycodone and Pregabalin; Drug: Oxycodone and placebo capsules; Drug: Pregabalin and NS; Drug: placebo capsules and NS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 264 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
• Anticipated Study Start Date: Apr 15, 2023
• Anticipated Primary Completion Date: Oct 15, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital	Beijing		China	100070

Sponsors and Collaborators

• Beijing Tiantan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruquan Han, Director of Anesthesiology Department, Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT05795478
• Other Study ID Numbers: sunQKT6660
• First Posted: Apr 3, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Postoperative Complications; Pregabalin; Oxycodone

Study Results

No Results Posted as of Apr 3, 2023