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NCT Number: NCT06743802

The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangyou Duan

Chongqing, Chongqing Municipality, 400010, China

Location status: Recruiting

Location contact

Guangyou Duan

CONTACT

[email protected]

(+86)18323376014

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Coenzyme Q10

Drug

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

Placebo

Other

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

Primary outcomes

  1. The incidence of chronic postsurgical pain

    Time frame: from the end of surgery to 3 months after surgery

Secondary outcomes

  1. 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.

    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)

  2. 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.

    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)

  3. The severity of chronic postsurgical pain

    Time frame: from the end of surgery to 3 months after surgery

    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)

  4. The incidence of neuropathic pain

    Time frame: from the end of surgery to 3 months after surgery

    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.

  5. 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.

  6. The dose of analgesic use

    Time frame: from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery.

  7. The quality of recovery score at 3 days Postoperatively

    Time frame: from the end of surgery to 3 days.

    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.

  8. Health related quality of life score at 3 months Postoperatively

    Time frame: from the end of surgery to 3 months after surgery.

    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.

  9. Postoperative length of hospital stay

    Time frame: from end of surgery to about 3 to 7 days after surgery.

  10. The incidence of adverse reactions

    Time frame: From admission to 3 month post-discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Guangyou Duan, ph.D

CONTACT

[email protected]

(+86)18323376014

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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