SurgeryNCT03562611
Postoperative Pain and Discomfort After Orbital Decompression
A study testing Nalbuphine, Flurbiprofen Axetil and Nalbuphine and Flurbiprofen Axetil in people with Surgery and Anesthesia, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Surgery, Anesthesia, Pain
- What is being tested?
- Nalbuphine, Flurbiprofen Axetil and Nalbuphine and Flurbiprofen Axetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2018to 30 Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-75 years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
- American Society of Anesthesiologists (ASA) physical status of I-II
Who cannot join
- body mass index (BMI) <18.5 or >35
- any uncontrolled clinical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression
The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.
Read the detailed description
To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression
- Conditions
- Surgery, Anesthesia, Pain
- Being tested
- Nalbuphine, Flurbiprofen Axetil, Nalbuphine and Flurbiprofen Axetil
- Keywords
- postoperative pain, general anesthesia, postoperative discomfort
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Nalbuphine administration during surgery
Flurbiprofen AxetilDrug
Flurbiprofen axetil administration during surgery
Nalbuphine and Flurbiprofen AxetilDrug
Nalbuphine and Flurbiprofen Axetil administration during surgery
| Study group | Role | What they receive |
|---|---|---|
| flurbiprofen axetil | Active comparator | flurbiprofen axetil intraoperative administration 100mg Receives: Drug: Flurbiprofen Axetil |
| nalbuphine | Experimental | nalbuphine intraoperative administration 0.1mg/kg Receives: Drug: Nalbuphine |
| nalbuphine and flurbiprofen axetil | Experimental | flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg Receives: Drug: Nalbuphine and Flurbiprofen Axetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after orbital decompression
Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).
Measured: 24 hour after recovery
Secondary outcomes (1)
Discomfort after orbital decompression
Discomfort levels were measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents the worst discomfort; this scale has been confirmed to be sensitive and reliable. Discomfort was defined as "sensation other than pain" and included nausea, vomiting, headache, and dizziness. Clinically significant postoperative discomfort was considered serious discomfort (NRS score ≥5) any time postoperatively.
Measured: 24 hour after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start8 Jun 2018
- Primary completion8 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
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, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562611
- Sponsor's protocol ID
- 201806
- Status last verified
- Dec 2018
- First submitted
- 7 Jun 2018
- Last updated
- 26 Dec 2018
- 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 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression
- ClinicalTrials.gov ID
- NCT03562611
- Acronym / sponsor ID
- 201806
- Conditions
- Surgery, Anesthesia, Pain
- Keywords
- postoperative pain, general anesthesia, postoperative discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Jun 2018 (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.
The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after orbital decompression under general anesthesia.
Detailed description
To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flurbiprofen axetil | Active comparator | Drug: Flurbiprofen Axetilflurbiprofen axetil intraoperative administration 100mg |
| nalbuphine | Experimental | Drug: Nalbuphinenalbuphine intraoperative administration 0.1mg/kg |
| nalbuphine and flurbiprofen axetil | Experimental | Drug: Nalbuphine and Flurbiprofen Axetilflurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 16-75 years old
- diagnosed as thyroid eye disease
- bone removal orbital decompression under general anesthesia
- American Society of Anesthesiologists (ASA) physical status of I-II
Key exclusion criteria (2 listed)
- body mass index (BMI) <18.5 or >35
- 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 |
|---|---|---|
| NalbuphineNalbuphine administration during surgery | Drug | nalbuphine |
| Flurbiprofen AxetilFlurbiprofen axetil administration during surgery | Drug | flurbiprofen axetil |
| Nalbuphine and Flurbiprofen AxetilNalbuphine and Flurbiprofen Axetil administration during surgery | Drug | nalbuphine and flurbiprofen axetil |
Primary outcome
Pain after orbital decompression
Time frame: 24 hour after recovery
Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).
1 secondary outcome
Discomfort after orbital decompression
Time frame: 24 hour after recovery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- 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 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 Nalbuphine, Flurbiprofen Axetil and Nalbuphine and Flurbiprofen Axetil in people with Surgery and Anesthesia, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 26 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after orbital decompression (time frame: 24 hour after recovery). 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 26 Dec 2018.