- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251439
Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring
Impact of Perioperative Body Temperature on Postoperative Complications and Pain in Video-assisted Thoracoscopic Surgery Patients Utilizing Continuous Temperature Monitoring: A Prospective Cohort Study
A report from the National Cancer Center (published in JNCC) shows that lung cancer has the highest rates of both new cases and deaths in China. Surgery using a tiny camera (thoracoscopic surgery) is a main treatment for early-stage lung cancer. However, this type of chest surgery carries a much higher risk of patients developing low body temperature during the operation compared to other surgeries. This is because: (1) The surgery is complex and takes longer; (2) The chest cavity is open and exposed to the cool operating room air; (3)General anesthesia affects the brain's ability to regulate temperature and widens blood vessels, causing faster heat loss.Studies show that low body temperature happens in about 65-73% of these chest surgeries, while the average for surgeries longer than 2 hours nationwide is only about 40%.
Low body temperature during surgery isn't just a problem at the time. It also increases the risk of negative outcomes after surgery. As known, it worsens post-surgery pain and increases risks of complications, such as infections, heart problems and bleeding issues.
A common pain control technique for chest surgery is injecting local anesthesia medicine near the spine (Thoracic Paravertebral Block or TPVB). This technique is very effective at reducing pain after surgery, both short-term and long-term. However, new research suggests this nerve block might cause blood vessels to widen, potentially making patients lose body heat faster during surgery. Because TPVB is used so often, it's hard to tell if low body temperature during surgery directly causes worse pain afterwards, or if the nerve block itself influences both temperature and pain. The potential connection between low temperature caused by TPVB and later pain is not yet clear.
The objective of this study is to investigate how low body temperature during and around the time of surgery affects complications after surgery (such as infections, heart and lung problems, longer hospital stays, etc.) in patients undergoing thoracic surgery. The investigators also aim to find the relationship between low body temperature during surgery and the occurrence of pain after surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiologist (ASA) I - III
- BMI 18.5 - 30 kg/m²
- Scheduled for Video-assisted thoracoscopic surgery (VATS) lung/mediastinal tumor resection (duration ≥1 hour)
- General anesthesia with regional block (thoracic paravertebral block and serratus anterior plane block)
- Written informed consent.
Exclusion Criteria:
- ASA ≥ IV
- Preoperative fever (>37.5°C) or hypothermia (<36.0°C)
- Chronic pain or opioid use ≥ 3 months
- Immunosuppression
- Thyroid dysfunction
- Neurological dysfunction affecting pain assessment
- Emergency surgery or conversion to thoracotomy
- Planned surgery <1 hour or requiring cardiopulmonary bypass
- Failed regional block (sensory block not covering T2-T8 at 4h postoperation)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative complications
Time Frame: From date of the operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 days
|
From date of the operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain intensity measured by Numeric Rating Scale on a scale from 0 to 10, where 0 indicates no pain and 10 signifies the worst possible pain. Scores between 1 and 3 typically represent mild pain, 4 to 6 moderate pain, and 7 to 10 severe pain.
Time Frame: From date of the operation until the date of complete remission, assessed up to 30 days
|
From date of the operation until the date of complete remission, assessed up to 30 days
|
|
Length of stay
Time Frame: From date of admission to hospital until the date of discharge, assessed up to 30 days
|
From date of admission to hospital until the date of discharge, assessed up to 30 days
|
|
ICU admission rate
Time Frame: From date of the operation until the date of discharge, assessed up to 30 days
|
From date of the operation until the date of discharge, assessed up to 30 days
|
|
30-day readmission rate
Time Frame: From date of discharge until the date of readmission, assessed up to 30 days
|
From date of discharge until the date of readmission, assessed up to 30 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Neurobehavioral Manifestations
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Lung Neoplasms
- Disease
- Agnosia
- Postoperative Complications
Other Study ID Numbers
- 2025-h067
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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