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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-18

Study Completion Date

2024-10-31

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.

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Detailed Description

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Conditions

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Pain, Postoperative Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

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Group 1: IV acetaminophen and PO placebo

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1000 mg of oral acetaminophen preoperatively administered

Group 2: PO acetaminophen

Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

1000 mg of oral acetaminophen preoperatively administered

Interventions

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Acetaminophen

1000 mg of oral acetaminophen preoperatively administered

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No