Efficacy of patient-controlled paravertebral block for single intercostal video assisted thoracic surgery

ISRCTN ISRCTN24097424
DOI https://doi.org/10.1186/ISRCTN24097424
Secondary identifying numbers N/A
Submission date
24/10/2016
Registration date
18/11/2016
Last edited
11/07/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Ming Wu
Scientific

Department of Thoracic Surgery
The Second Affiliated Hospital of Zhejiang University
Hangzhou
31000
China

Study information

Study designSingle-center randomized study
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleA 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
Study objectivesParavertebral 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(s)Ethics Committee of the Second Affiliated Hospital of Zhejiang University, 08/05/2015
Health condition(s) or problem(s) studiedPain in the postoperative period
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measurePain after surgery, measured using visual analogue score (VAS) until day 3 after surgery
Secondary outcome measures1. 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 study start date01/06/2015
Completion date31/01/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants130 patients in each group
Key inclusion criteria1. Patients diagnosed with solitary pulmonary nodule and spontaneous pneumothorax
2. Suitable for single intercostal video assisted thoracic surgery
3. Aged 18 to 80
Key exclusion criteria1. Patients with unresectable tumors
2. Older than 80 years old
Date of first enrolment01/06/2015
Date of final enrolment31/12/2016

Locations

Countries of recruitment

  • China

Study participating centre

Second Affiliated Hospital of Zhejiang University
No. 88 Jiefang Road
Hangzhou
310000
China

Sponsor information

Second Affiliated Hospital of Zhejiang University
Hospital/treatment centre

No. 88 Jiefang Road
Hangzhou
31000
China

ROR logo "ROR" https://ror.org/059cjpv64

Funders

Funder type

Hospital/treatment centre

Second Affiliated Hospital of Zhejiang University (China)

No information available

Results and Publications

Intention to publish date31/01/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Zixiang Wu (zixiang0717@126.com)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2018 Yes No

Editorial Notes

11/07/2018: Publication reference added.
12/10/2017: internal review.