Condition category
Signs and Symptoms
Date applied
24/10/2016
Date assigned
18/11/2016
Last edited
12/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Ming Wu

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Second Affiliated Hospital of Zhejiang University

Sponsor details

No. 88 Jiefang Road
Hangzhou
31000
China

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/10/2017: internal review.