- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03847363
The Influence of Different Anesthesia on Acute and Chronic Postsurgical Pain After Thoracic Surgery
February 18, 2019 updated by: Shanghai Zhongshan Hospital
The Influence of Different Anesthesia and Postoperative Pain Management on Acute and Chronic Postsurgical Pain After Thoracic Surgery: a Prospective Study
This study would compare acute and chronic postsurgical pain in patients underwent thoracic surgery with different anesthesia and analgesia methods, and explore the influencing factors.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Chronic postsurgical pain (CPSP) was the pain caused by the operation that exceeded the healing time of normal tissue (usually 3 months), that was, a status that the damage caused by noxious stimulus had been healed, but the pain that cannot be explained by disease and inflammation were still existed.
Due to the location of the incision and the necessity of indwelling the chest tube, the thoracic lung surgery was considered to be one of the most painful surgical operations.
Studies have found that the incidences of CPSP in patients with thoracotomy were 57% (95% CI, 51-64%) and 47% (95% CI, 39-56%) at postoperative 3 and 6 months, respectively.
With the development of minimally invasive techniques, thoracic surgery had gradually become less traumatic, and the number of surgical incisions was gradually developed into single port.Through ages, epidural analgesia with a combination of local anesthetics and opioids had long been considered the "gold standard" for postoperative analgesia in thoracic surgery.
However, with the development of clinical anesthetics and the widespread use of nerve block techniques, it had been found that in open radical gastrectomy, there was no significant difference in the inhibition of intraoperative stress response between dexmedetomidine combined with general anesthesia and a combined general-epidural anesthesia.
So, which anesthesia and analgesia method was "perfect" for a specific type of surgery procedure?
This study would compare acute and chronic postsurgical pain in patients underwent different thoracic surgery procedure with different anesthesia and analgesia methods, and explore the influencing factors.
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: shuwei wang
- Phone Number: +8613564440601
- Email: veronciawang228@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital, Fudan University
-
Contact:
- Jing Cang, PhD
- Phone Number: 2331 86-21-64041990
- Email: cang.jing@zs-hospital.sh.cn
-
Principal Investigator:
- shuwei wang, MD
-
Sub-Investigator:
- min fei, MD
-
Sub-Investigator:
- Hong ZHANG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients underwent selective thoracic surgery meeting inclusion and exclusion criteria
Description
Inclusion Criteria:
- ASA I-II
- underwent selective thoracic surgery
Exclusion Criteria:
- with severe cardiac, endocrine,immunologic or haematologic diseases
- medical history of chronic pain problems in chest area
- medical history of pain-relief or sedative medication
- not able to communicate with investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
general anesthesia
patients underwent general anesthesia
|
|
general and epidural anesthesia
patients underwent general and epidural anesthesia
|
epidural anesthesia
|
general anesthesia combined with nerve block
patients underwent general anesthesia combined with nerve block
|
paravertebral or serratus anterior plane block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
numerical rating scale of acute postsurgical pain
Time Frame: at day1 post-operation
|
numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.
|
at day1 post-operation
|
numerical rating scale of acute postsurgical pain
Time Frame: at day2 post-operation
|
numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.
|
at day2 post-operation
|
numerical rating scale of chronic postsurgical pain
Time Frame: at 3rd month post-operation
|
numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.
|
at 3rd month post-operation
|
numerical rating scale of chronic postsurgical pain
Time Frame: at 6th month post-operation
|
numerical rating scale is a 11-point scale for patient self-reporting of pain, in which 0 stands for no pain and 10 stands for the most severe pain.
|
at 6th month post-operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: jing cang, Shanghai Zhongshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
July 30, 2020
Study Registration Dates
First Submitted
February 10, 2019
First Submitted That Met QC Criteria
February 18, 2019
First Posted (Actual)
February 20, 2019
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cpsp-revisited
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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