Comparing IV and oral acetaminophen for pain management during spine surgery
Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
This study is testing whether giving acetaminophen through an IV during spine surgery helps manage pain better than taking it by mouth before the surgery for patients having lumbar discectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rothman Institute Orthopaedics Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04574778 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intraoperative intravenous (IV) acetaminophen compared to preoperative oral acetaminophen in managing postoperative pain for patients undergoing ambulatory lumbar discectomy. The study will measure outcomes such as opioid usage, patient-reported pain scores, adverse effects related to opioids, and the time taken for recovery and discharge from the post-anesthesia care unit. By focusing on non-opioid analgesics, the trial seeks to enhance patient experience and improve discharge efficiency in same-day surgery settings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old, weighing more than 50 kg, and classified as ASA physical status I-III.
Not a fit: Patients with chronic pain conditions unrelated to back pain or those who are opioid tolerant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that reduce reliance on opioids after spine surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches to pain management using non-opioid analgesics, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Philadelphia, Pennsylvania
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.