Paravertebral block versus thoracic epidural analgesia for video-assisted thoracic surgery
| ISRCTN | ISRCTN20639281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20639281 |
| Secondary identifying numbers | 2019-451 |
- Submission date
- 09/01/2020
- Registration date
- 23/01/2020
- Last edited
- 06/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
A thoracotomy is a surgery to open the chest. Post-thoracotomy pain can lead to a high incidence of postoperative complications, such as pneumonia and atelectasis, if not adequately controlled. Video-assisted thoracic surgery (VATS) is considered to be less painful and safer and requires a shorter hospital stay than thoracotomy. However, pain remains an issue associated with VATS, especially for the first three days after surgery.
There are numerous pain management options for VATS, including non-steroidal anti-inflammatory drugs (NSAIDs), epidural analgesia, systemic opioids, paravertebral block (PVB), patient-controlled analgesia (PCA), and surgical wound infiltration. The researchers have demonstrated that PVB, which results in lower cumulative dezocine doses and produces fewer side effects than PCA, can provide effective pain relief for patients undergoing VATS. However, TEA has been regarded as the gold standard for managing acute pain after thoracic surgery. The aim of this study is to test whether PVB has similar pain control when compared with TEA.
Who can participate?
Patients aged 18-80, without chronic pain (with no pain medications routinely used), could provide consent to participate and precisely complete a pain assessment, and have resectable solitary pulmonary nodules.
What does the study involve?
Participants are randomly allocated into one of two groups. Participants in the first group undergo single intercostal VATS and afterwards receive patient-controlled PVB for pain relief. Participants in the second group receive thoracic epidural analgesia for pain relief and then undergo single intercostal VATS. All participants’ pain levels are assessed, and the number of patients who require extra medication on the three days after the operation is recorded.
What are the possible benefits and risks of participating?
Effective analgesia and fewer side effects are possible benefits. Postoperative analgesic failure is a possible risk.
Where is the study run from?
Second Affiliated Hospital of Zhejiang University (China)
When is the study starting and how long is it expected to run for?
January 2020 to January 2021
Who is funding the study?
Second Affiliated Hospital of Zhejiang University (China)
Who is the main contact?
Prof. Ming Wu
iwuming22@zju.edu.cn
Contact information
Public
No. 88 Jiefang Road
Hangzhou
31009
China
| Phone | +86 (0)13757118715 |
|---|---|
| iwuming22@zju.edu.cn |
Study information
| Study design | Single-center randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomized clinical trial to assess the efficacy of patient-controlled paravertebral block versus thoracic epidural analgesia for patients undergoing single intercostal video-assisted thoracic surgery |
| Study objectives | It has been demonstrated that paravertebral block, which resulted in lower cumulative dezocine doses and produced fewer side effects than intravenous patient-controlled analgesia, can provide effective pain relief for patients undergoing video-assisted thoracic surgery. However, epidural analgesia has been regarded as the gold standard for managing acute pain after thoracic surgery. This randomized study was designed to test whether paravertebral block has similar pain control when compared with epidural analgesia. |
| Ethics approval(s) | Approved 22/12/2019, Ethics Committee of the Second Affiliated Hospital of Zhejiang University (No. 88 Jiefang Road, Hangzhou city, Zhejiang province, China, 310009; Tel: +86 (0)571 87783759; Email: HREC2013@126.com), ref: 2019-451 |
| Health condition(s) or problem(s) studied | Pain in the postoperative period |
| Intervention | Patients were randomly allocated by a computer-generated random number list to receive patient-controlled PVB (PVB group) or thoracic epidural analgesia (TEA group) for postoperative analgesia before being transferred to the operating room. 1. In the PVB group, patients receive single intercostal video-assisted thoracic surgery and patient-controlled paravertebral block for postoperative analgesia. 2. In the TEA group, patients receive thoracic epidural analgesia for postoperative analgesia and single intercostal video-assisted thoracic surgery In the case of analgesic failure, intramuscular dezocine 10 mg (Jiangsu, China) was used as rescue medication. The chest tube was removed when there was no air leakage and the volume of drainage was less than 100 mL/24 hours. The criteria for hospital discharge included chest tube removal, adequate oral intake, pain controlled by oral analgesics and assessment of patients’ well-being by their attending doctors. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using the visual analogue score (VAS) in the state of rest and coughing postoperatively at 1, 6, 24, 48, and 72 hours |
| Secondary outcome measures | 1. The number of patients who required rescue medication and the cumulative dezocine dose administered during postoperative days (PODs) 0-3, recorded at 8:00 on PODs 1-4 2. Quality of life measured using the European Organization for Research and Treatment of Cancer (EORCT) general quality of life questionnaire (QLQ-C30) within 1 days prior to surgery, 3 days after the operation 3. Overall satisfaction with analgesic modality measured using a 5-point scale (1=dissatisfied, 5=satisfied) on POD 3 4. Complications after surgery, such as nausea and vomiting, hypertension, chylothorax and atrial fibrillation, recorded after surgery and before discharge |
| Overall study start date | 31/01/2020 |
| Completion date | 31/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | About 85 patients in each group |
| Total final enrolment | 176 |
| Key inclusion criteria | Patients diagnosed with solitary pulmonary nodules and without chronic pain (with no pain medications routinely used) deemed suitable to undergo three-port single-intercostal VATS by surgeons |
| Key exclusion criteria | Patients with other malignancies |
| Date of first enrolment | 01/02/2020 |
| Date of final enrolment | 30/06/2022 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Hospital/treatment centre
No. 88 Jiefang Road
Hangzhou city
31009
China
| Phone | +86 (0)13757118715 |
|---|---|
| iwuming22@zju.edu.cn | |
| Website | http://en.z2hospital.com/ |
"ROR" |
https://ror.org/059cjpv64 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Additional documents (such as study protocol, statistical analysis plan etc) will not available in web format, please use the contact details to contact Ming Wu. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Ming Wu (iwuming22@zju.edu.cn). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/08/2023 | 06/06/2024 | Yes | No |
Editorial Notes
06/06/2024: Publication reference and total final enrolment added.
27/11/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2020 to 30/06/2022.
2. The overall trial end date has been changed from 31/01/2021 to 31/07/2022.
3. The intention to publish date has been changed from 31/01/2022 to 31/12/2023.
20/01/2020: Trial's existence confirmed by Ethics Committee of the Second Affiliated Hospital of Zhejiang University.
