Chronic Post Operative PainNCT05795478
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery
A study testing Oxycodone and Pregabalin and Pregabalin and NS in people with Chronic Post Operative Pain and Oxycodone, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Post Operative Pain, Oxycodone, Pregabalin
- What is being tested?
- Oxycodone and Pregabalin and Pregabalin and NS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective spinal surgery
- Ages equal to or more than 18 years old
- ASA I-III
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@ccmu.edu.cn
About this study
Official title: Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
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.
- Being tested
- Oxycodone and Pregabalin, Oxycodone and placebo capsules, Pregabalin and NS, placebo capsules and NS
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone and PregabalinDrug
Oxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1~7,75mg QD for POD8~14
Oxycodone and placebo capsulesDrug
Oxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point
Pregabalin and NSDrug
Pregabalin: 150mg preoperatively, 75mg BID for POD1~7,75mg QD for POD8~14 NS: Equal volume NS for 3 days postoperatively
placebo capsules and NSDrug
placebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Combined group | Experimental | Oxycodone+Pregabalin Receives: Drug: Oxycodone and Pregabalin |
| Oxycodone group | Other | Oxycodone+placebo capsules Receives: Drug: Oxycodone and placebo capsules |
| Pregabalin group | Other | NS+Pregabalin Receives: Drug: Pregabalin and NS |
| Control group | Placebo comparator | NS+placebo capsules Receives: Drug: placebo capsules and NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of CPSP
The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start24 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post Operative PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph D., Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795478
- Sponsor's protocol ID
- sunQKT6660
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial
- ClinicalTrials.gov ID
- NCT05795478
- Acronym / sponsor ID
- sunQKT6660
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Drug: Oxycodone and PregabalinOxycodone+Pregabalin |
| Oxycodone group | Other | Drug: Oxycodone and placebo capsulesOxycodone+placebo capsules |
| Pregabalin group | Other | Drug: Pregabalin and NSNS+Pregabalin |
| Control group | Placebo comparator | Drug: placebo capsules and NSNS+placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective spinal surgery
- Ages equal to or more than 18 years old
- ASA I-III
- Signed informed consent
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone and PregabalinOxycodone: 150mg PCIA during 3 days postoperatively Pregabalin: 150mg preoperatvely, 75mg BID for POD1~7,75mg QD for POD8~14 | Drug | Combined group |
| Oxycodone and placebo capsulesOxycodone: 150mg PCIA for 3 days postoperatively placebo capsules: same numbers as pregabalin at each time point | Drug | Oxycodone group |
| Pregabalin and NSPregabalin: 150mg preoperatively, 75mg BID for POD1~7,75mg QD for POD8~14 NS: Equal volume NS for 3 days postoperatively | Drug | Pregabalin group |
| placebo capsules and NSplacebo capsules: same numbers as pregabalin at each time point NS: Equal volume NS for 3 days postoperatively | Drug | Control group |
Primary outcome
the incidence of CPSP
Time frame: 3 months after surgery
The incidence of chronic postsurgical pain, the CPSP was defined as an NRS score >3 (0~10).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Han, M.D., Ph D. study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone and Pregabalin and Pregabalin and NS in people with Chronic Post Operative Pain and Oxycodone, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D., Ph D. (8610-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of CPSP (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.