Postoperative Pain
Conditions
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.
Interventions
DRUGCoenzyme Q10
Coenzyme Q10 was administered from admission to one month after discharge at a dose of 200 mg per day (200 mg/qd).
OTHERPlacebo
The placebo was administered from hospital admission until one month after discharge.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of chronic postsurgical pain | from the end of surgery to 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | — |
| The dose of analgesic use | from the end of surgery to 6 hours,12 hours, 24 hours and 48 hours after surgery. | — |
Countries
China
Contacts
Primary ContactGuangyou Duan, ph.D
Outcome results
None listed