Lumbar Spinal StenosisNCT04042948
Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery
A study testing Tylenol in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy
- What is being tested?
- Tylenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 30 Dec 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patient
- diagnosis of lumbar spinal stenosis
- perform decompression and fusion surgery and lay a drainage tube
- understand the test and could sign the name
Who cannot join
- beside the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study of Fever Probability, Risk Factors and Preventive Use of Non-steroidal Anti-inflammatory Drugs on Fever After Removal of Drainage Tube After Lumbar Fusion
This study evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.
- Being tested
- Tylenol
- Keywords
- lumbar spinal stenosis, lumbar fusion surgery, drainage tube, removal of drainage tube, fever, prevention of fever, preventive use of non-steroidal inflammatory drug
- Medical subject headings
- Spinal Stenosis, Intervertebral Disc Displacement, Radiculopathy, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TylenolDrug
when we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | preventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube Receives: Drug: Tylenol |
| Control Group | No intervention | without any intervention when remove the drainage tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of fever after the removal of drainage tube
we test the temperature of the patient in 24h after the removal of tube, we define fever if the temperature is higher than 37.8 degree
Measured: 24 hours
Secondary outcomes (4)
the level of WBC
we compare the change of the level of WBC of two groups in 24h after the removal of the drainage tube
Measured: 24 hours
the level of CRP
we compare the change of the level of CRP of two groups in 24h after the removal of the drainage tube
Measured: 24 hours
the level of ESR
we compare the change of the level of ESR of two groups in 24h after the removal of the drainage tube
Measured: 24 hours
the temperature
we compare the change of the level of temperature of two groups in 24h after the removal of the drainage tube
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start24 Jun 2019
- Primary completion30 Nov 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Tian, M.D, Principal investigator, Peking University Third Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042948
- Sponsor's protocol ID
- IRB00006761-M2019299
- Status last verified
- Jun 2021
- First submitted
- 13 Jul 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Fever Probability, Risk Factors and Preventive Use of Non-steroidal Anti-inflammatory Drugs on Fever After Removal of Drainage Tube After Lumbar Fusion
- ClinicalTrials.gov ID
- NCT04042948
- Acronym / sponsor ID
- IRB00006761-M2019299
- Keywords
- lumbar spinal stenosis, lumbar fusion surgery, drainage tube, removal of drainage tube, fever, prevention of fever, preventive use of non-steroidal inflammatory drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 2 Aug 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 evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Tylenolpreventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube |
| Control Group | No intervention | –without any intervention when remove the drainage tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patient
- diagnosis of lumbar spinal stenosis
- perform decompression and fusion surgery and lay a drainage tube
- understand the test and could sign the name
Key exclusion criteria (1 listed)
- beside the inclusion criteria
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 |
|---|---|---|
| Tylenolwhen we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later | Drug | Experimental Group |
Primary outcome
the rate of fever after the removal of drainage tube
Time frame: 24 hours
we test the temperature of the patient in 24h after the removal of tube, we define fever if the temperature is higher than 37.8 degree
4 secondary outcomes
the level of WBC
Time frame: 24 hours
the level of CRP
Time frame: 24 hours
the level of ESR
Time frame: 24 hours
the temperature
Time frame: 24 hours
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 18 Jun 2021.
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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.
Yun Tian, M.D principal investigator
Peking University Third Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tylenol in people with Lumbar Spinal Stenosis and Lumbar Disc Herniation, run by Peking University Third 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 4 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: finished, as of the sponsor's last update on 18 Jun 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?
the rate of fever after the removal of drainage tube (time frame: 24 hours). 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 18 Jun 2021.