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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative, Spine Surgery

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: IV acetaminophen and PO placebo<br>Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery | Drug: Acetaminophen<br>* 1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure<br>|
| Active Comparator: Group 2: PO acetaminophen<br>Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo. | Drug: Acetaminophen<br>* 1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid usage | Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | assessed 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) | 1 day | 
| Number of patients who report nausea or vomiting | this will be a count of the number of patients who report nausea or vomiting in recovery room | 1 day | 
| Mean pain score | (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 | 1 day |