Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Prof Ming Wu
ORCID ID
Contact details
No. 88 Jiefang Road
Hangzhou
31009
China
+86 (0)13757118715
iwuming22@zju.edu.cn
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019-451
Study information
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
Acronym
Study hypothesis
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
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
Study design
Single-center randomized study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
31/01/2020
Overall trial end date
31/01/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
About 85 patients in each group
Participant exclusion criteria
Patients with other malignancies
Recruitment start date
01/02/2020
Recruitment end date
31/12/2020
Locations
Countries of recruitment
China
Trial participating centre
Second Affiliated Hospital, Zhejiang University School of Medicine
31009
China
Sponsor information
Organisation
Second Affiliated Hospital of Zhejiang University
Sponsor details
No. 88 Jiefang Road
Hangzhou city
31009
China
+86 (0)13757118715
iwuming22@zju.edu.cn
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Second Affiliated Hospital of Zhejiang University (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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).
Intention to publish date
31/01/2022
Participant level data
Available on request
Basic results (scientific)
Publication list