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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
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 13, 2019
Last Updated
June 17, 2021
Sponsor
Peking University Third Hospital
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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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