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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Post Operative Pain Oxycodone Pregabalin Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Combined group

Oxycodone+Pregabalin

Group Type EXPERIMENTAL

Oxycodone and Pregabalin

Intervention Type DRUG

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

Oxycodone group

Oxycodone+placebo capsules

Group Type OTHER

Oxycodone and placebo capsules

Intervention Type DRUG

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

Pregabalin group

NS+Pregabalin

Group Type OTHER

Pregabalin and NS

Intervention Type DRUG

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

Control group

NS+placebo capsules

Group Type PLACEBO_COMPARATOR

placebo capsules and NS

Intervention Type DRUG

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

Interventions

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Oxycodone and Pregabalin

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

Intervention Type DRUG

Oxycodone and placebo capsules

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

Intervention Type 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

Intervention Type DRUG

placebo capsules and NS

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No