SurgeryNCT03422887
Nalbuphine and Flurbiprofen for Oculoplastic Surgery
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 oculoplastic surgery 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
- 330 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 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
- Undergoing oculoplastic surgery
- age between 16 and 75 years
- American Society of Anesthesiologists (ASA) physical status of I-II
Who cannot join
- serious coexisting disease
- body mass index (BMI) <18.5 or >35
- contraindications or previous adverse reactions to any of the drugs used
- females with a positive pregnancy test
- patients unable to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery
The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.
Read the detailed description
In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.
- 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 24 hours 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).
Measured: 24 hours after recovery
Secondary outcomes (1)
Discomfort 24 hours after recovery
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 posted6 Feb 2018
- Study start18 Jan 2018
- Primary completion31 Aug 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
- 330 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, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422887
- Sponsor's protocol ID
- 201802
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2018
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. 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 Oculoplastic Surgery
- ClinicalTrials.gov ID
- NCT03422887
- Acronym / sponsor ID
- 201802
- Conditions
- Surgery, Anesthesia, Pain
- Keywords
- postoperative pain, general anesthesia, postoperative discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 6 Feb 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 oculoplastic surgery under general anesthesia.
Detailed description
In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.
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 (3 listed)
- Undergoing oculoplastic surgery
- age between 16 and 75 years
- American Society of Anesthesiologists (ASA) physical status of I-II
Key exclusion criteria (5 listed)
- serious coexisting disease
- body mass index (BMI) <18.5 or >35
- contraindications or previous adverse reactions to any of the drugs used
- females with a positive pregnancy test
- patients unable to cooperate
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 24 hours after recovery
Time frame: 24 hours 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 24 hours after recovery
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 1 Feb 2021.
- 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 study director
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 3 inclusion and 5 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 1 Feb 2021. 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 24 hours after recovery (time frame: 24 hours 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 1 Feb 2021.