A Phase 3 interventional study of Acetaminophen in Pain, Postoperative and Spine Surgery, sponsored by Rothman Institute Orthopaedics. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Rothman Institute Orthopaedics · Phase 3, Interventional, and Other
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 82 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Postoperative opioid usage
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents
Time frame: 1 day
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)
Time frame: 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
Time frame: 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
Time frame: 1 day
Plan to share: No
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Rothman Institute Orthopaedics