Lung CancerNCT05478460
Acute and Chronic Pain After Video-assisted Thoracoscopic Surgery for Lung Cancer
An observational study of Lung Cancer, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to evaluate whether preoperative CT- guided hookwire localization would influence the incidence and intensity of acute and chronic pain after VATS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hookwire localization
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 21 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The institutional review board approved this prospective study. This study included 138 consecutive patients who underwent CT-guided localization before VATS , of which 69 using hookwire (Group A) and 69 without hookwire (Group B). The inclusion criteria were as follows: patients were planned to underwent VATS for lung cancer .
Who may be able to join
- Aged 18-75
- patients who underwent underwent CT-guided localization before VATS
- ASA I-II
- BMI 18.5-30
- no serious complications after localization
- sign informed consent
Who cannot join
- could not complish underwent CT-guided localization
- selfexpression or visual dysfunction
- having emergency surgery
- a severe psychiatric illness
- having chronic pain problems in the chest area
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, 200032
About this study
Official title: Acute and Chronic Pain After Video-assisted Thoracoscopic Surgery for Lung Cancer in Patients With Preoperative CT-guided Hookwire Localization
The aim of this study is to evaluate whether preoperative CT- guided hookwire localization would influence the incidence and intensity of acute and chronic pain after VATS.
Read the detailed description
Postoperative pain after thoracic surgery has gained recognition as a adverse outcome and head-scratching problem. The incidence of choric postoperative pain (CPSP) in thoracic surgery has been reported to be 20%-80%. However, there has been not an standard treatment for CPSP. Many study has showed the risk factors of CPSP in thoracic surgery, such as VATS type, operation time, duration of drainage, preoperative pain, repeat surgery, gender, postoperative chemotherapy or radiation therapy , etc. It is important that moderate-to-severe acute postoperative pain will be transformed into CPSP. That offers a new management goal in postoperative pain prevention.CT-guided hookwire localization have been proven to be benefical for VATS to diagnose and treat small pulmonary , it can shorten operation timing and increase surgery success rate. However, it causes roughly 23.8% severe pain and complaints included wire dislodgement, pneumothorax and haemorrhage during and after insertion. The question is whether or not the moderate-to-severe acute postoperative pain from hookwire localition will change the incidence and intensity of CPSP in VATS.
Nurses play a pivotal role in advanced practice, research, and education in the field of pain management. The pain management of hookwire localization may be a new vison in further research.
- Conditions
- Lung Cancer
- Being tested
- Hookwire localization
- Keywords
- Lung cancer, Video-assisted Thoracoscopic Surgery, hookwire location
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hookwire localizationOther
Patients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Before operation,patients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule. Receives: Other: Hookwire localization | |
| Group B | without hookwire localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative incidence and intensity of chronic pain after surgery
the incidence and severity（11-point numerical rating scale,0=painless, 10=woest pain）of pain was assessed after VATS operation
Measured: at postoperative 3rd month
postoperative incidence and intensity of chronic pain after surgery
the incidence and severity（11-point numerical rating scale, 0=painless, 10=worst pain）of pain was assessed after VATS operation
Measured: at postoperative 6th month
Secondary outcomes (3)
postoperative length of stay in hospital
the days between postoperative 1st day and day of discharge from hospital
Measured: an average of 1 week
satisfactory score
Likert score (from 1 to 5),higher scores mean a better outcome
Measured: from the day discharge from hospital to postoperative 6th month
intensity of postoperative acute pain
the severity(11-point numerical rating scale, 0=no pain, 10=worst pain) after VATS operation
Measured: from immediately after surgery(at postanesthesia care unit ) to postoperative 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start10 Aug 2021
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
- Investigators
- Jun Zhang, PhD, Principal investigator, Department of Anesthesiology, Fudan University Shanghai Cancer Center;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478460
- Sponsor's protocol ID
- pain assessment after VATS
- Status last verified
- Oct 2022
- First submitted
- 30 May 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Pain After Video-assisted Thoracoscopic Surgery for Lung Cancer in Patients With Preoperative CT-guided Hookwire Localization
- ClinicalTrials.gov ID
- NCT05478460
- Acronym / sponsor ID
- pain assessment after VATS
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Video-assisted Thoracoscopic Surgery, hookwire location
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether preoperative CT- guided hookwire localization would influence the incidence and intensity of acute and chronic pain after VATS.
Detailed description
Postoperative pain after thoracic surgery has gained recognition as a adverse outcome and head-scratching problem. The incidence of choric postoperative pain (CPSP) in thoracic surgery has been reported to be 20%-80%. However, there has been not an standard treatment for CPSP. Many study has showed the risk factors of CPSP in thoracic surgery, such as VATS type, operation time, duration of drainage, preoperative pain, repeat surgery, gender, postoperative chemotherapy or radiation therapy , etc. It is important that moderate-to-severe acute postoperative pain will be transformed into CPSP. That offers a new management goal in postoperative pain prevention.CT-guided hookwire localization have been proven to be benefical for VATS to diagnose and treat small pulmonary , it can shorten operation timing and increase surgery success rate. However, it causes roughly 23.8% severe pain and complaints included wire dislodgement, pneumothorax and haemorrhage during and after insertion. The question is whether or not the moderate-to-severe acute postoperative pain from hookwire localition will change the incidence and intensity of CPSP in VATS.
Nurses play a pivotal role in advanced practice, research, and education in the field of pain management. The pain management of hookwire localization may be a new vison in further research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Hookwire localizationBefore operation,patients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule. |
| Group B | – | –without hookwire localization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The institutional review board approved this prospective study. This study included 138 consecutive patients who underwent CT-guided localization before VATS , of which 69 using hookwire (Group A) and 69 without hookwire (Group B). The inclusion criteria were as follows: patients were planned to underwent VATS for lung cancer .
Key inclusion criteria (6 listed)
- Aged 18-75
- patients who underwent underwent CT-guided localization before VATS
- ASA I-II
- BMI 18.5-30
- no serious complications after localization
Key exclusion criteria (6 listed)
- could not complish underwent CT-guided localization
- selfexpression or visual dysfunction
- having emergency surgery
- a severe psychiatric illness
- having chronic pain problems in the chest area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hookwire localizationPatients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule. | Other | Group A |
Primary outcome
postoperative incidence and intensity of chronic pain after surgery
Time frame: at postoperative 3rd month
the incidence and severity（11-point numerical rating scale,0=painless, 10=woest pain）of pain was assessed after VATS operation
postoperative incidence and intensity of chronic pain after surgery
Time frame: at postoperative 6th month
the incidence and severity（11-point numerical rating scale, 0=painless, 10=worst pain）of pain was assessed after VATS operation
3 secondary outcomes
postoperative length of stay in hospital
Time frame: an average of 1 week
satisfactory score
Time frame: from the day discharge from hospital to postoperative 6th month
intensity of postoperative acute pain
Time frame: from immediately after surgery(at postanesthesia care unit ) to postoperative 2nd day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, PhD principal investigator
Department of Anesthesiology, Fudan University Shanghai Cancer Center;
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative incidence and intensity of chronic pain after surgery (time frame: at postoperative 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.