Postoperative PainNCT02704715
Postoperative Pain in Orbital Disease and Ocular Tumor
A study testing general anesthesia,orbital operation in people with Postoperative Pain, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- general anesthesia,orbital operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Dec 2018
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- over 16 years old
- diagnosed as orbital disease or ocular tumor
- surgery under general anesthesia
Who cannot join
- any uncontrolled clinical problems
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510000
Huijing Ye, Master, 00862087331539, yehuijing@qq.com
Huasheng Yang, Doctor, 00862087331539, yanghs64@126.com
About this study
Official title: Postoperative Pain of General Anesthesia in Orbital Disease and Ocular Tumor
The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.
Read the detailed description
The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.
- Conditions
- Postoperative Pain
- Being tested
- general anesthesia,orbital operation
- Keywords
- postoperative pain, general 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 anesthesia,orbital operationProcedure or surgery
to evaluate the pain under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia,orbital operation | Other | 1. diagnosed as orbital disease and ocular tumor
2. over 16 years old
3. orbital operation under general anesthesia Receives: Procedure: general anesthesia,orbital operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
numerical rating scale, NRS will be used to measure the pain
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 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 Sun Yat-sen UniversityThe 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijing Ye, Sun Yat-sen University
- Investigators
- Huijing Ye, Master, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704715
- Sponsor's protocol ID
- 2016MEKY006
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain of General Anesthesia in Orbital Disease and Ocular Tumor
- ClinicalTrials.gov ID
- NCT02704715
- Acronym / sponsor ID
- 2016MEKY006
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- 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.
The purpose of this study is to evaluate the postoperative pain after general anesthesia of orbital diseases and ocular tumor patients.
Detailed description
The purpose of this study is to evaluate patients diagnosed of orbital diseases or ocular tumor over 16 years old of the postoperative pain after general anesthesia , and to analyze the related factors of pain after operation.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general anesthesia,orbital operation | Other | Procedure: general anesthesia,orbital operation1. diagnosed as orbital disease and ocular tumor 2. over 16 years old 3. orbital operation under general anesthesia |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- over 16 years old
- diagnosed as orbital disease or ocular tumor
- surgery under general anesthesia
Key exclusion criteria (1 listed)
- any uncontrolled clinical problems
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 anesthesia,orbital operationto evaluate the pain under general anesthesia | Procedure or surgery | general anesthesia,orbital operation |
Primary outcome
pain
Time frame: 24 hours after surgery
numerical rating scale, NRS will be used to measure the pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- 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.
Huijing Ye, Master principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general anesthesia,orbital operation in people with Postoperative Pain, run by Sun Yat-sen University 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 3 inclusion and 1 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 10 Mar 2016. 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 Huijing Ye, Master (+00862087331539, yehuijing@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 24 hours after surgery). 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 10 Mar 2016.