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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03847363
Other study ID # cpsp-revisited
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date July 30, 2020

Study information

Verified date February 2019
Source Shanghai Zhongshan Hospital
Contact shuwei wang
Phone +8613564440601
Email veronciawang228@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
epidural anesthesia
epidural anesthesia
nerve block
paravertebral or serratus anterior plane block

Locations

Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary numerical rating scale of acute postsurgical pain 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
Primary numerical rating scale of acute postsurgical pain 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
Primary numerical rating scale of chronic postsurgical pain 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
Primary numerical rating scale of chronic postsurgical pain 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
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