ClinicalTrials.gg
Status unknownNCT05795478Updated Aug 1, 2024

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

An interventional study of Oxycodone and Pregabalin and Oxycodone and placebo capsules in Chronic Post Operative Pain, Oxycodone and Pregabalin, sponsored by Beijing Tiantan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Post Operative Pain
  • Oxycodone
  • Pregabalin
  • Postoperative Complications
03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's planned enrollment of 264 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    Combined group

    Oxycodone+Pregabalin

    Drug: Oxycodone and Pregabalin

  • Other
    Oxycodone group

    Oxycodone+placebo capsules

    Drug: Oxycodone and placebo capsules

  • Other
    Pregabalin group

    NS+Pregabalin

    Drug: Pregabalin and NS

  • Placebo comparator
    Control group

    NS+placebo capsules

    Drug: placebo capsules and NS

Interventions

  • DrugOxycodone and Pregabalin

    Drug pages: Oxycodone · Pregabalin

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

  • DrugOxycodone and placebo capsules

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

  • DrugPregabalin and NS

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

  • Drugplacebo capsules and NS

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

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What researchers measure

Primary outcomes

  1. the incidence of CPSP

    The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score \>3 (0\~10).

    Time frame: 3 months after surgery

07

Study locations

1 of 1 sites recruiting
  • Beijing Tiantan Hospital
    Beijing, 100070, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05795478
Responsible party
Ruquan Han (Director of Anesthesiology Department, Beijing Tiantan Hospital) — Principal investigator
First posted
Apr 3, 2023
Start date
Oct 24, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 1, 2024

Study contacts

Ruquan Han, M.D., Ph D.
Contact
ruquan.han@ccmu.edu.cn
8610-59976660
Ruquan Han, M.D., Ph D.
study chair · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Oxycodone · Pregabalin

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