Back to resultsEffects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
Primary Purpose
Chronic Post Operative Pain, Oxycodone, Pregabalin
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oxycodone and Pregabalin
Oxycodone and placebo capsules
Pregabalin and NS
placebo capsules and NS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Post Operative Pain
Eligibility Criteria
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.
Sites / Locations
- Beijing Tiantan Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Other
Placebo Comparator
Arm Label
Combined group
Oxycodone group
Pregabalin group
Control group
Arm Description
Oxycodone+Pregabalin
Oxycodone+placebo capsules
NS+Pregabalin
NS+placebo capsules
Outcomes
Primary Outcome Measures
the incidence of CPSP
The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).
Secondary Outcome Measures
Full Information
NCT ID
NCT05795478
First Posted
March 21, 2023
Last Updated
March 31, 2023
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05795478
Brief Title
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
Official Title
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post Operative Pain, Oxycodone, Pregabalin, Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined group
Arm Type
Experimental
Arm Description
Oxycodone+Pregabalin
Arm Title
Oxycodone group
Arm Type
Other
Arm Description
Oxycodone+placebo capsules
Arm Title
Pregabalin group
Arm Type
Other
Arm Description
NS+Pregabalin
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
NS+placebo capsules
Intervention Type
Drug
Intervention Name(s)
Oxycodone and Pregabalin
Intervention Description
Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1~7,75mg QD for POD8~14
Intervention Type
Drug
Intervention Name(s)
Oxycodone and placebo capsules
Intervention Description
Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
Intervention Type
Drug
Intervention Name(s)
Pregabalin and NS
Intervention Description
Pregabalin: 150mg preoperatively, 75mg BID for POD1~7,75mg QD for POD8~14 NS: Equal volume NS for 3 days postoperatively
Intervention Type
Drug
Intervention Name(s)
placebo capsules and NS
Intervention Description
placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively
Primary Outcome Measure Information:
Title
the incidence of CPSP
Description
The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruquan Han, M.D., Ph D.
Phone
8610-59976660
Email
ruquan.han@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@ccmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
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