NCT04574778

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Spine Surgery

Interventions

Type	Name	Description
DRUG	Acetaminophen	1000 mg of oral acetaminophen preoperatively administered

Timeline

• Start date: 2021-03-18
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2020-10-05
• Last updated: 2024-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study