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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Spine Surgery
• Intervention / Treatment: Drug: Acetaminophen

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Rothman Orthopaedic Institute
      • Contact: Thema Nicholson, MSc; Phone Number: 267-339-3615; Email: thema.nicholson@rothmanortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Acetaminophen; 1000 mg of oral acetaminophen preoperatively administered
Active Comparator: Group 2: PO acetaminophen; Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.	Drug: Acetaminophen; 1000 mg of oral acetaminophen preoperatively administered

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: GSCHR19D.660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No