Plain English Summary
Background and study aims
Video-assisted thoracic surgery is a type of surgery where a camera is used to view the inside of the chest cavity after making only very small incisions. It is considered to be less painful, safer and requires a shorter hospital stay compared with thoracotomy (surgical opening of the chest). However, pain remains an issue after surgery, especially for the first three days after surgery. Paravertebral block, where local anaesthetic is injected through a catheter (tube) to ‘block’ the spinal nerve, has been proven to control pain after thoracotomy. The aim of this study is to find out whether patient-controlled paravertebral block can provide pain relief for patients compared with the usual pain management.
Who can participate?
Patients aged 18 to 80 who require video-assisted thoracic surgery
What does the study involve?
Participants are randomly allocated into one of two groups. Participants in the first group undergo surgery and afterwards receive patient-controlled paravertebral block for pain relief. Participants in the second group undergo surgery and afterwards receive patient-controlled pain relief intravenously (injected into a vein). 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?
Participants may benefit from pain relief and fewer side effects. The possible risk is that the treatment may fail to relieve pain.
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?
June 2015 to January 2017
Who is funding the study?
Second Affiliated Hospital of Zhejiang University (China)
Who is the main contact?
Prof. Ming Wu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomized clinical trial to assess the efficacy of patient-controlled paravertebral block versus intravenous patients controlled analgesia for patients undergoing single intercostal video assisted thoracic surgery
Acronym
Study hypothesis
Paravertebral block has been proven to be effective for pain control after thoracotomy and the traditional approach in performing paravertebral block is by inserting a needle 2.5 to 4 cm lateral to the spinous process of the thoracic vertebra and using the loss of resistance as the superior costotransverse ligament is traversed. In this study, a catheter was placed in the paravertebral space under thoracoscopic guidance by the surgeon for patients undergoing single intercostal video assisted thoracic surgery and this randomized study was designed to testify this technique can also provide effective analgesia for patients comparing with our usual single intercostal video assisted thoracic surgery pain management.
Hypothesis: Patients controlled paravertebral block after single intercostal video assisted thoracic surgery can provide effective analgesia and fewer side effects than intravenous patients controlled analgesia.
Ethics approval
Ethics Committee of the Second Affiliated Hospital of Zhejiang University, 08/05/2015
Study design
Single-center randomized study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Pain in the postoperative period
Intervention
Patients are randomised into two groups:
1. In the PVB group, patients receive single intercostal video-assisted thoracic surgery and patient-controlled paravertebral block for postoperative analgesia.
2. In the PCA group, patients receive single intercostal video-assisted thoracic surgery and intravenous patient-controlled analgesia for postoperative analgesia.
Intramuscular dezocine is used as a rescue medication for both groups. The chest tube is removed when there is no air leakage during coughing and the volume of drainage is less than 100ml/24h. Patients are discharged after removal.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Pain after surgery, measured using visual analogue score (VAS) until day 3 after surgery
Secondary outcome measures
1. The number of patients who receive rescue medication, measured on postoperative days 0, 1, 2 and 3
2. Complications after surgery, such as nausea and vomiting, hypertension, chylothorax and atrial fibrillation, measured after surgery and before discharge
3. The number of patients who are capable of a good cough, measured on postoperative days 0, 1, 2 and 3
4. Total hospital stay, measured on discharge
5. Time in the ICU, measured on discharge
6. Mortality within 30 days
Overall trial start date
01/06/2015
Overall trial end date
31/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients diagnosed with solitary pulmonary nodule and spontaneous pneumothorax
2. Suitable for single intercostal video assisted thoracic surgery
3. Aged 18 to 80
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130 patients in each group
Participant exclusion criteria
1. Patients with unresectable tumors
2. Older than 80 years old
Recruitment start date
01/06/2015
Recruitment end date
31/12/2016
Locations
Countries of recruitment
China
Trial participating centre
Second Affiliated Hospital of Zhejiang University
No. 88 Jiefang Road
Hangzhou
310000
China
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
To be confirmed at a later date
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Zixiang Wu (zixiang0717@126.com)
Intention to publish date
31/01/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29763594