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

Phase 3

Recruiting

• Conditions: Pain, Postoperative; Spine Surgery
• Interventions: Drug: Acetaminophen

• Registration Number: NCT04574778
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2021-03-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: PO acetaminophen	Acetaminophen	Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.
Group 1: IV acetaminophen and PO placebo	Acetaminophen	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

Primary Outcome Measures

Name	Time	Method
Postoperative opioid usage	1 day	Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Number of patients who report nausea or vomiting	1 day	this will be a count of the number of patients who report nausea or vomiting in recovery room
Mean pain score	1 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
Quality of recovery	1 day	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)

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States