Postoperative PainPhase 4NCT06743802
The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery
A Phase 4 study testing Coenzyme Q10 in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to 20 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years;
- American Society of Anesthesiology (ASA) physical status classification I-III;
- Scheduled for elective lung resection surgery under thoracoscopy;
- Voluntarily opting for patient-controlled intravenous analgesia;
- Willing to participate in this trial after consultation with the patient or their family and signing the informed consent form.
Who cannot join
- History of previous thoracotomy or thoracoscopic surgery;
- Patients converted to open thoracotomy intraoperatively;
- Severe hepatic or renal dysfunction;
- History of substance abuse;
- Pregnancy or breastfeeding;
- History of chronic pain;
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- Use of coenzyme Q10 for more than one month;
- Allergy to coenzyme Q10;
- Patients unable to communicate or cooperate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangyou Duan
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, (+86)18323376014, duangy@hospital.cqmu.edu.cn
About this study
Official title: The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery: a Randomized Controlled Trial
This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.
- Conditions
- Postoperative Pain
- Being tested
- Coenzyme Q10, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd).
PlaceboOther
The placebo was administered from hospital admission until one month after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 | Experimental | Not described Receives: Drug: Coenzyme Q10 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic postsurgical pain
Measured: from the end of surgery to 3 months after surgery
Secondary outcomes (10)
The incidence of acute postoperative pain with a score ≥4
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score. (NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The severity of acute postoperative pain
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The severity of chronic postsurgical pain
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Measured: from the end of surgery to 3 months after surgery
The incidence of neuropathic pain
The DN4 questionnaire (Douleur Neuropathique 4) was used to evaluate neuropathic pain. The DN4 is a validated diagnostic tool consisting of 10 items, with scores ranging from 0 to 10. A score of 4 or higher indicates the presence of neuropathic pain.
Measured: from the end of surgery to 3 months after surgery
The frequency of postoperative rescue analgesic use
Measured: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The dose of analgesic use
Measured: from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery.
The quality of recovery score at 3 days Postoperatively
The QoR-15 scale, ranging from 0 to 150 with higher scores indicating better recovery, was used to assess the quality of recovery on postoperative day 3.
Measured: from the end of surgery to 3 days.
Health related quality of life score at 3 months Postoperatively
The SF-8 scale, with a scoring range of 0 to 100 where higher scores indicate better physical and mental health, was used to evaluate health-related quality of life at 3 months postoperatively.
Measured: from the end of surgery to 3 months after surgery.
Postoperative length of hospital stay
Measured: from end of surgery to about 3 to 7 days after surgery.
The incidence of adverse reactions
Measured: From admission to 3 month post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start9 Jan 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743802
- Sponsor's protocol ID
- Coenzyme Q10 and pain
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu J, Li L, Luo L, Wu N, Xu F, Tao C, Chen J, Huang H, Duan G. Effect of coenzyme Q10 on pain prevention after thoracoscopic surgery: study protocol. Pain Manag. 2025 Dec;15(12):889-896. doi: 10.1080/17581869.2025.2567832. Epub 2025 Sep 30.
PubMed 41025845
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06743802
- Acronym / sponsor ID
- Coenzyme Q10 and pain
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 20 Dec 2024 (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.
This study aimed to assess the effectiveness of Coenzyme Q10 in preventing both acute and chronic pain following thoracoscopic surgery, with a focus on its potential benefits in reducing the incidence and severity of pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Experimental | Drug: Coenzyme Q10 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75 years;
- American Society of Anesthesiology (ASA) physical status classification I-III;
- Scheduled for elective lung resection surgery under thoracoscopy;
- Voluntarily opting for patient-controlled intravenous analgesia;
- Willing to participate in this trial after consultation with the patient or their family and signing the informed consent form.
Key exclusion criteria (9 listed)
- History of previous thoracotomy or thoracoscopic surgery;
- Patients converted to open thoracotomy intraoperatively;
- Severe hepatic or renal dysfunction;
- History of substance abuse;
- Pregnancy or breastfeeding;
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 |
|---|---|---|
| Coenzyme Q10Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd). | Drug | Coenzyme Q10 |
| PlaceboThe placebo was administered from hospital admission until one month after discharge. | Other | Placebo |
Primary outcome
The incidence of chronic postsurgical pain
Time frame: from the end of surgery to 3 months after surgery
10 secondary outcomes
The incidence of acute postoperative pain with a score ≥4
Time frame: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The severity of acute postoperative pain
Time frame: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The severity of chronic postsurgical pain
Time frame: from the end of surgery to 3 months after surgery
The incidence of neuropathic pain
Time frame: from the end of surgery to 3 months after surgery
The frequency of postoperative rescue analgesic use
Time frame: from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.
The dose of analgesic use
Time frame: from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery.
The quality of recovery score at 3 days Postoperatively
Time frame: from the end of surgery to 3 days.
Health related quality of life score at 3 months Postoperatively
Time frame: from the end of surgery to 3 months after surgery.
Postoperative length of hospital stay
Time frame: from end of surgery to about 3 to 7 days after surgery.
The incidence of adverse reactions
Time frame: From admission to 3 month post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 41025845Liu J, Li L, Luo L, Wu N, Xu F, Tao C, Chen J, Huang H, Duan G. Effect of coenzyme Q10 on pain prevention after thoracoscopic surgery: study protocol. Pain Manag. 2025 Dec;15(12):889-896. doi: 10.1080/17581869.2025.2567832. Epub 2025 Sep 30.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangyou Duan, ph.D ((+86)18323376014, duangy@hospital.cqmu.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 chronic postsurgical pain (time frame: from the end of surgery to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743802, which also lists 1 linked publication.
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 26 Feb 2025.