NCT04042948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

July 13, 2019

Last Update Submit

June 17, 2021

Conditions

Keywords

lumbar spinal stenosislumbar fusion surgerydrainage tuberemoval of drainage tubefeverprevention of feverpreventive use of non-steroidal inflammatory drug

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (4)

  • the level of WBC

    24 hours

  • the level of CRP

    24 hours

  • the level of ESR

    24 hours

  • the temperature

    24 hours

Study Arms (2)

Experimental Group

EXPERIMENTAL

preventive use non-steroidal anti-inflammatory drugs to before the removal of drainage tube

Drug: Tylenol

Control Group

NO INTERVENTION

without any intervention when remove the drainage tube

Interventions

when we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Haidian, 110191, China

Location

MeSH Terms

Conditions

Spinal StenosisIntervertebral Disc DisplacementRadiculopathyFever

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBody Temperature ChangesSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Yun Tian, M.D

    Peking University Third Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomized control parallel
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2019

First Posted

August 2, 2019

Study Start

June 24, 2019

Primary Completion

November 30, 2019

Study Completion

December 30, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations