Postoperative PainPhase 1CDAAMIUVLSNCT03311737
Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
A Phase 1 study testing general anesthesia and epidural anesthesia in people with Postoperative Pain and Single-incision Thoracoscopic Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Single-incision Thoracoscopic Surgery
- What is being tested?
- general anesthesia and epidural anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2017to 31 Mar 2018
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients elective uniportal VATS lung surgery;
- BMI 18-30 kg/m2.
Who cannot join
- Patient refuse;
- ASA≥3;
- Patients allergic to use anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
yi li, Ph.D, 13816836628, loulan_queen@163.com
xiangting li, B.S., 13671864990, 524646417@qq.com
About this study
This is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.
Read the detailed description
Combining epidural with general anesthesia is regarded as the gold standard of general thoracic surgery. The uniportal VATS lung surgery have advantages of minimal invasive surgical incision, less postoperative pain, and so on. Whether general anesthesia can become an alternative method of combining epidural with general anesthesia in uniportal VATS lung surgery, investigators thus plan to make a comparison on intraoperative stress response, postoperative pain, immune function of patients，and hospital expenses.
- Being tested
- general anesthesia, epidural anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anesthesiaCombination product
The investigators used general anesthesia preoperatively in uniportal VATS lung surgery
epidural anesthesiaCombination product
The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia group | Experimental | The patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively. Receives: Combination Product: general anesthesia |
| epidural group | Active comparator | The patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively. Receives: Combination Product: epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale（VAS）
This scale mainly reflects the patient's pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start19 Sep 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311737
- Sponsor's protocol ID
- zs20170511
- Acronym
- CDAAMIUVLS
- Status last verified
- Sep 2017
- First submitted
- 23 Sep 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
- ClinicalTrials.gov ID
- NCT03311737
- Acronym / sponsor ID
- CDAAMIUVLS / zs20170511
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 17 Oct 2017 (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 is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.
Detailed description
Combining epidural with general anesthesia is regarded as the gold standard of general thoracic surgery. The uniportal VATS lung surgery have advantages of minimal invasive surgical incision, less postoperative pain, and so on. Whether general anesthesia can become an alternative method of combining epidural with general anesthesia in uniportal VATS lung surgery, investigators thus plan to make a comparison on intraoperative stress response, postoperative pain, immune function of patients，and hospital expenses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia group | Experimental | Combination Product: general anesthesiaThe patients in this group receive general anesthesia preoperatively, and use patient controlled intravenous analgesia postoperatively. |
| epidural group | Active comparator | Combination Product: epidural anesthesiaThe patients in this group receive general anesthesia combined with epidural anesthesia, and use patient controlled epidural analgesia postoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients elective uniportal VATS lung surgery;
- BMI 18-30 kg/m2.
Key exclusion criteria (3 listed)
- Patient refuse;
- ASA≥3;
- Patients allergic to use anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.
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 |
|---|---|---|
| general anesthesiaThe investigators used general anesthesia preoperatively in uniportal VATS lung surgery | Combination product | general anesthesia group |
| epidural anesthesiaThe investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery | Combination product | epidural group |
Primary outcome
visual analogue scale（VAS）
Time frame: 1 year
This scale mainly reflects the patient's pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing general anesthesia and epidural anesthesia in people with Postoperative Pain and Single-incision Thoracoscopic Surgery, 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 3 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 17 Oct 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yi li, Ph.D (13816836628, loulan_queen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale（VAS） (time frame: 1 year). 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 17 Oct 2017.