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Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy

Not Applicable
Conditions
Pain
Interventions
Registration Number
NCT02067442
Lead Sponsor
Thomas Jefferson University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Single level lumbar micro disk surgery
  • Ages 18-65

Exclusion Criteria

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

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
oral acetaminophenoral acetaminophenPatients in this arm of the study will receive oral acetaminophen and an IV placebo
intravenous acetaminophenintravenous acetaminophenPatients in this arm of the study will receive IV acetaminophen and an oral placebo
Primary Outcome Measures
NameTimeMethod
Postoperative pain scoresDay of surgery

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.

Secondary Outcome Measures
NameTimeMethod
Quantity of intraoperative and postoperative opioids administered.Day of surgery

All doses of opioids given on the day of surgery will be recorded.

Trial Locations

Locations (1)

Thomas Jefferson University Hopsital

🇺🇸

Philadelphia, Pennsylvania, United States

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