Clinical trial

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

Name

sunQKT6660

Description

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.

Trial arms

Trial start

2023-04-15

Estimated PCD

2024-10-15

Trial end

2024-12-31

Status

Not yet recruiting

Treatment

Oxycodone and Pregabalin

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

Arms:

Combined group

Oxycodone and placebo capsules

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

Arms:

Oxycodone group

Pregabalin and NS

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

Arms:

Pregabalin group

placebo capsules and NS

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

Arms:

Control group

Size

264

Primary endpoint

the incidence of CPSP

3 months after surgery

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 264, 'type': 'ESTIMATED'}}

Updated at

2023-04-03

1 organization

4 products

4 indications

Organization

Beijing Tiantan Hospital

Product

Oxycodone + Pregabalin

Indication

Chronic Postoperative Pain

Indication