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

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

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • 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.

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

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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