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

NCT05795478 | Recruiting DMC

• 1 other identifier: sunQKT6660
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post Operative Pain; Oxycodone; Pregabalin; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Combined group

EXPERIMENTAL

Oxycodone+Pregabalin

Drug: Oxycodone and Pregabalin

Oxycodone group

OTHER

Oxycodone+placebo capsules

Drug: Oxycodone and placebo capsules

Pregabalin group

OTHER

NS+Pregabalin

Drug: Pregabalin and NS

Control group

PLACEBO COMPARATOR

NS+placebo capsules

Drug: placebo capsules and NS

Interventions

Oxycodone and Pregabalin DRUG

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

Combined group

Oxycodone and placebo capsules DRUG

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

Oxycodone group

Pregabalin and NS DRUG

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

Pregabalin group

placebo capsules and NS DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing elective spinal surgery
• Ages equal to or more than 18 years old
• ASA I-III
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications

Interventions

Oxycodone; Pregabalin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ruquan Han, M.D., Ph D.

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Ruquan Han, M.D., Ph D.

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: October 24, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

CN (1)