NCT06743802

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

February 26, 2025

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

December 7, 2024

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The incidence of chronic postsurgical pain

    from the end of surgery to 3 months after surgery

Secondary Outcomes (10)

  • The incidence of acute postoperative pain with a score ≥4

    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

    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

    from the end of surgery to 3 months after surgery

  • The incidence of neuropathic pain

    from the end of surgery to 3 months after surgery

  • The frequency of postoperative rescue analgesic use

    from the end of surgery to 6 hours,12 hours, 24 hours , 48 hours and 72 hours after surgery.

  • +5 more secondary outcomes

Study Arms (2)

Coenzyme Q10

EXPERIMENTAL
Drug: Coenzyme Q10

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd).

Coenzyme Q10
PlaceboOTHER

The placebo was administered from hospital admission until one month after discharge.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Use of coenzyme Q10 for more than one month;
  • Allergy to coenzyme Q10;
  • Patients unable to communicate or cooperate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangyou Duan

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2024

First Posted

December 20, 2024

Study Start

January 9, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

February 26, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Locations