Condition category
Surgery
Date applied
09/01/2020
Date assigned
23/01/2020
Last edited
20/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://en.z2hospital.com/

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

Publication citations

Additional files

Editorial Notes

20/01/2020: Trial's existence confirmed by Ethics Committee of the Second Affiliated Hospital of Zhejiang University.