Acute PainNCT03847363
The Influence of Different Anesthesia on Acute and Chronic Postsurgical Pain After Thoracic Surgery
An observational study of Acute Pain and Chronic Postsurgical Pain, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Pain, Chronic Postsurgical Pain
- What is being tested?
- epidural anesthesia and nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients underwent selective thoracic surgery meeting inclusion and exclusion criteria
Who may be able to join
- ASA I-II
- underwent selective thoracic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jing Cang, PhD, 86-21-64041990 ext. 2331, cang.jing@zs-hospital.sh.cn
shuwei wang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Pain, Chronic Postsurgical Pain
- Being tested
- epidural anesthesia, nerve block
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural anesthesiaProcedure or surgery
epidural anesthesia
nerve blockProcedure or surgery
paravertebral or serratus anterior plane block
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | patients underwent general anesthesia | |
| general and epidural anesthesia | patients underwent general and epidural anesthesia Receives: Procedure: epidural anesthesia | |
| general anesthesia combined with nerve block | patients underwent general anesthesia combined with nerve block Receives: Procedure: nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day1 post-operation
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.
Measured: at day2 post-operation
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.
Measured: at 3rd month post-operation
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.
Measured: at 6th month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jing cang, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847363
- Sponsor's protocol ID
- cpsp-revisited
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Anesthesia and Postoperative Pain Management on Acute and Chronic Postsurgical Pain After Thoracic Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT03847363
- Acronym / sponsor ID
- cpsp-revisited
- Conditions
- Acute Pain, Chronic Postsurgical Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 20 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | –patients underwent general anesthesia |
| general and epidural anesthesia | – | Procedure: epidural anesthesiapatients underwent general and epidural anesthesia |
| general anesthesia combined with nerve block | – | Procedure: nerve blockpatients underwent general anesthesia combined with nerve block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients underwent selective thoracic surgery meeting inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- ASA I-II
- underwent selective thoracic surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural anesthesiaepidural anesthesia | Procedure or surgery | general and epidural anesthesia |
| nerve blockparavertebral or serratus anterior plane block | Procedure or surgery | general anesthesia combined with nerve block |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jing cang study chair
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Chronic Postsurgical Pain, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shuwei wang (+8613564440601, veronciawang228@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale of acute postsurgical pain (time frame: at day1 post-operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.