The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Coenzyme Q10; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Guangyou Duan, ph.D; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Guangyou Duan
      • Contact: Guangyou Duan; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; The placebo was administered from hospital admission until one month after discharge.
Experimental: Coenzyme Q10	Drug: Coenzyme Q10; Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of chronic postsurgical pain	from the end of surgery to 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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.	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.
The dose of analgesic use		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.	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.	from the end of surgery to 3 months after surgery.
Postoperative length of hospital stay		from end of surgery to about 3 to 7 days after surgery.
The incidence of adverse reactions		From admission to 3 month post-discharge

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Micronutrients; Vitamins; Ubiquinone; Coenzyme Q10
• Other Study ID Numbers: Coenzyme Q10 and pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No