The Effect of Coenzyme Q10 in Preventing Pain After Thoracoscopic Surgery

Phase 4

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Coenzyme Q10; Other: Placebo

• Registration Number: NCT06743802
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-20
• Study Start: 2025-01-09
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-03-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10	Coenzyme Q10	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The incidence of chronic postsurgical pain	from the end of surgery to 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
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.	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)
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.	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)
The severity of chronic postsurgical pain	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)
The incidence of neuropathic pain	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.
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	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.
Health related quality of life score at 3 months Postoperatively	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.
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

Trial Locations

Locations (1)

Guangyou Duan; 🇨🇳 Chongqing, Chongqing, China