NCT02067442

Brief Summary

Both intravenous and oral acetaminophen have been shown to reduce post-operative pain scores when given preoperatively. This study investigates if there is a difference between the intravenous and the oral forms when given preoperatively to patients undergoing lumbar microdiscectomy. We hypothesize that the intravenous formulation does not improve pain scores or decrease opioid consumption during the first postoperative day compared to the oral formulation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

January 17, 2014

Last Update Submit

March 17, 2015

Conditions

Pain

Keywords

acetaminophen intravenous oral pain scores opioids

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores

    Pain scores are measured using a visual analog scale with patient at rest and also with movement of the lower extremities at four separate times following surgery.

    Day of surgery

Secondary Outcomes (1)

  • Quantity of intraoperative and postoperative opioids administered.

    Day of surgery

Study Arms (2)

oral acetaminophen

ACTIVE COMPARATOR

Patients in this arm of the study will receive oral acetaminophen and an IV placebo

Drug: oral acetaminophen

intravenous acetaminophen

ACTIVE COMPARATOR

Patients in this arm of the study will receive IV acetaminophen and an oral placebo

Drug: intravenous acetaminophen

Interventions

oral acetaminophenDRUG

1000 milligrams given orally before surgery

Also known as: Tylenol
oral acetaminophen
intravenous acetaminophenDRUG

1000 milligrams of intravenous acetaminophen given before surgery

Also known as: Ofirmev
intravenous acetaminophen

Eligibility Criteria

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

You may qualify if:

  • Single level lumbar micro disk surgery
  • Ages 18-65

You may not qualify if:

  • morbid obesity
  • prior back surgery
  • opioid tolerance
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Marc D Fisicaro, MD

CONTACT

215-955-6161marc.fisicaro@jefferson.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 20, 2014

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)