Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery
Primary Purpose
Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tylenol
Sponsored by
About this trial
This is an interventional prevention trial for Lumbar Spinal Stenosis focused on measuring lumbar spinal stenosis, lumbar fusion surgery, drainage tube, removal of drainage tube, fever, prevention of fever, preventive use of non-steroidal inflammatory drug
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- beside the inclusion criteria
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
preventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube
without any intervention when remove the drainage tube
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
the temperature
we compare the change of the level of temperature of two groups in 24h after the removal of the drainage tube
Full Information
NCT ID
NCT04042948
First Posted
July 13, 2019
Last Updated
June 17, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04042948
Brief Title
Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 happening when we remove the tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis, Lumbar Disc Herniation, Lumbar Radiculopathy
Keywords
lumbar spinal stenosis, lumbar fusion surgery, drainage tube, removal of drainage tube, fever, prevention of fever, preventive use of non-steroidal inflammatory drug
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomized control parallel
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
preventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
without any intervention when remove the drainage tube
Intervention Type
Drug
Intervention Name(s)
Tylenol
Intervention Description
when we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later
Primary Outcome Measure Information:
Title
the rate of fever after the removal of drainage tube
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
the level of WBC
Description
we compare the change of the level of WBC of two groups in 24h after the removal of the drainage tube
Time Frame
24 hours
Title
the level of CRP
Description
we compare the change of the level of CRP of two groups in 24h after the removal of the drainage tube
Time Frame
24 hours
Title
the level of ESR
Description
we compare the change of the level of ESR of two groups in 24h after the removal of the drainage tube
Time Frame
24 hours
Title
the temperature
Description
we compare the change of the level of temperature of two groups in 24h after the removal of the drainage tube
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
beside the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Tian, M.D
Organizational Affiliation
Peking University Third Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Haidian
ZIP/Postal Code
110191
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery
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