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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than 18 years-old

• Weight greater than 50 kg body weight

• ASA physical status I-III

• English-speaking

Locations
United States
Pennsylvania
Rothman Orthopaedic Institute
RECRUITING
Philadelphia
Time Frame
Start Date: 2021-03-18
Estimated Completion Date: 2024-10-31
Participants
Target number of participants: 82
Treatments
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
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.
Related Therapeutic Areas
Sponsors
Leads: Rothman Institute Orthopaedics

This content was sourced from clinicaltrials.gov