Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT07203079
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen Oral Tablet — DRUG
    Participants take 1000mg by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
  • placebo oral tablet — DRUG
    Participants take one placebo tablet (matchable to tylenol) by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
  • Acetaminophen infusion — DRUG
    Participants take 1000mg by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
  • Placebo infusion — DRUG
    Participants take 1000mg placebo by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.

Study Details

The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery

Key Dates

Start date
Jan 31, 2026
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral Acetaminophen 1000mg
    Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery
  • Experimental: Intravenous Acetaminophen 1000mg
    Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery

Primary Outcome Measure

Numerical Rating Scale (NRS) Pain Intensity Scale Score [ Time Frame: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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Stanford University· Stanford, CA

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