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Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy

Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04574778
Enrollment
82
Registered
2020-10-05
Start date
2021-03-18
Completion date
2024-10-31
Last updated
2024-01-12

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

Conditions

Pain, Postoperative, Spine Surgery

Brief summary

Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.

Interventions

DRUGAcetaminophen

1000 mg of oral acetaminophen preoperatively administered

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Only those performing postoperative assessments and the participants will be blinded.

Eligibility

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

Inclusion criteria

* Age greater than 18 years-old * Weight greater than 50 kg body weight * ASA physical status I-III * English-speaking

Exclusion criteria

* Weight less than 50 kg * Pregnancy or breast feeding * revision surgery * Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc) * Chronic pain conditions unrelated to back pain * Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid usage1 dayPostoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents

Secondary

MeasureTime frameDescription
Quality of recovery1 dayassessed using the Quality of Recovery 15 scale, with a range of 0-150 (0 is the worst score and 150 is the best possible recovery)
Number of patients who report nausea or vomiting1 daythis will be a count of the number of patients who report nausea or vomiting in recovery room
Mean pain score1 day(0-10 numerical rating scale where 0=no pain and 10=worst pain imaginable) - this will be the mean pain rating upon entering pacu and at least 1 other time point in each study group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026