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

Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02067442
Enrollment
100
Registered
2014-02-20
Start date
2013-08-31
Completion date
Unknown
Last updated
2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

acetaminophen intravenous oral pain scores opioids

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.

Interventions

1000 milligrams given orally before surgery

1000 milligrams of intravenous acetaminophen given before surgery

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scoresDay of surgeryPain 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

MeasureTime frameDescription
Quantity of intraoperative and postoperative opioids administered.Day of surgeryAll doses of opioids given on the day of surgery will be recorded.

Countries

United States

Contacts

Primary ContactMarc D Fisicaro, MD
marc.fisicaro@jefferson.edu215-955-6161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026