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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05478460
Other study ID # pain assessment after VATS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date July 21, 2022

Study information

Verified date October 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date July 21, 2022
Est. primary completion date July 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hookwire localization
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.

Locations

Country Name City State
China 270 Dongan Road, Fudan University Shanghai Cancer Center Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at postoperative 3rd month
Primary 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 at postoperative 6th month
Secondary postoperative length of stay in hospital the days between postoperative 1st day and day of discharge from hospital an average of 1 week
Secondary satisfactory score Likert score (from 1 to 5),higher scores mean a better outcome from the day discharge from hospital to postoperative 6th month
Secondary intensity of postoperative acute pain the severity(11-point numerical rating scale, 0=no pain, 10=worst pain) after VATS operation from immediately after surgery(at postanesthesia care unit ) to postoperative 2nd day
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