A Phase 4 interventional study of Naproxen and Acetaminophen in Opioid Abuse (Disorder), Opioid Analgesia and Opioid Analgesic Adverse Reaction, sponsored by AdventHealth. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by AdventHealth · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to evaluate strategies for optimizing postoperative multimodal pain regimens and reducing opioid dependency in patients undergoing upper extremity surgery. The main questions it aims to answer are:
Researchers will compare three groups of participants receiving distinct standard-of-care pain management regimens to see how pill volume variations and gabapentin integration affect recovery.
Participants will:
This randomized controlled trial evaluates the efficacy of multimodal analgesic regimens to maximize postoperative pain relief while minimizing opioid dependency in patients undergoing hand, wrist, or elbow surgery. The study explores two distinct clinical concepts: first, whether changing the physical pill burden (quantity and frequency) of non-opioid medications alters perceived pain management; and second, whether integrating gabapentin permits a 50% reduction in initial opioid prescriptions without compromising analgesia. A total of around 251 adult participants will be randomized with an equal allocation probability into one of three standard-of-care medication arms:
Group 1 (High Pill Count Non-Opioid): Naproxen 250 mg (2 pills twice daily for 7 days; 1,000 mg/day) + Acetaminophen 325 mg (2 pills 4 times daily for 7 days; 2,600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
Group 2 (Low Pill Count Non-Opioid / Control): Naproxen 500 mg (1 pill twice daily for 7 days; 1,000 mg/day) + Acetaminophen 650 mg (1 pill 4 times daily for 7 days; 2,600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
Group 3 (Gabapentin Multimodal / Reduced Opioid): Naproxen 500 mg (1 pill twice daily for 7 days; 1,000 mg/day) + Acetaminophen 650 mg (1 pill 4 times daily for 7 days; 2,600 mg/day) + Gabapentin 300 mg (1 pill twice daily for 7 days; 600 mg/day) + Oxycodone 5 mg (1 pill 4 times daily for 1.5 days; 6 pills total).
Primary Objectives and Comparisons:
Analgesic Effect of Non-Opioid Pill Volume: By comparing Group 1 and Group 2, researchers will evaluate if a higher physical volume of non-opioid pills taken at a greater dosing frequency provides superior self-reported pain control compared to a lower pill volume, despite both groups receiving identical cumulative daily milligram dosages of non-opioids and opioids.
Opioid Reduction via Gabapentin Integration: By comparing Group 3 to Group 2, researchers will evaluate if the addition of gabapentin provides sufficient additive analgesia to allow for a 50% reduction in the post-operative oxycodone supply (6 pills vs. 12 pills) without increasing patient pain scores or the rate of subsequent prescription refill requests.
Data Collection Schedule:
Participant outcomes will be tracked during structured follow-up telephone interviews conducted at 3 days and 2 weeks post-surgery. The data points collected at these intervals include patient-reported pain scores (0-10 visual scale), the exact number of remaining opioid pills, occurrences of medication-related adverse effects, and records of any formal postoperative refill requests.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →AdventHealth is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
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Exclusion Criteria:
Participants receive a standard cumulative daily dose of non-opioid medications split into lower individual strengths to increase the physical pill count and dosing frequency. The regimen consists of Naproxen 250 mg (2 pills twice daily for 7 days), Acetaminophen 325 mg (2 pills 4 times daily for 7 days), and a standard course of Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
Drug: Naproxen · Drug: Acetaminophen · Drug: oxycodone
Participants receive a standard cumulative daily dose of non-opioid medications utilizing standard individual pill strengths, resulting in a lower physical pill burden. The regimen consists of Naproxen 500 mg (1 pill twice daily for 7 days), Acetaminophen 650 mg (1 pill 4 times daily for 7 days), and a standard course of Oxycodone 5 mg (1 pill 4 times daily for 3 days; 12 pills total).
Drug: Naproxen · Drug: Acetaminophen · Drug: oxycodone
Participants receive a multimodal regimen that incorporates gabapentin alongside standard non-opioid medications, allowing for a 50% reduction in the total physical quantity of prescribed opioids. The regimen consists of Naproxen 500 mg (1 pill twice daily for 7 days), Acetaminophen 650 mg (1 pill 4 times daily for 7 days), Gabapentin 300 mg (1 pill twice daily for 7 days), and a shortened course of Oxycodone 5 mg (1 pill 4 times daily for 1.5 days; 6 pills total).
Drug: Naproxen · Drug: Acetaminophen · Drug: oxycodone · Drug: Gabapentin
An oral nonsteroidal anti-inflammatory drug (NSAID) administered postoperatively for 7 days to provide baseline anti-inflammatory analgesia. Dosing varies by arm assignment (250 mg tablets vs. 500 mg tablets) to evaluate the impact of physical pill burden.
An oral non-opioid analgesic administered postoperatively 4 times daily for 7 days. Dosing varies by arm assignment (325 mg tablets vs. 650 mg tablets) to evaluate the impact of physical pill burden.
An oral short-acting mu-opioid receptor agonist administered postoperatively as needed for breakthrough pain. Total pill quantity varies by arm assignment, providing either a standard 3-day course (12 pills total) or a reduced 1.5-day course (6 pills total).
An oral anticonvulsant/gabapentinoid administered postoperatively at 300 mg twice daily for 7 days as part of a multimodal non-opioid strategy to enable a shortened opioid course.
Number of Participants Requesting an Additional Postoperative Pain Medication Refill
A binary tracking (yes/no) of whether a participant formally contacts the investigator or clinical staff to request a prescription refill for postoperative pain management during the study period.
Time frame: Through 2 weeks post-surgery
Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery
Patient-reported pain will be measured using a standard visual scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain possible". Higher scores indicate a worse pain outcome.
Time frame: 3 days post-surgery
Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery
Patient-reported pain will be measured using a standard visual scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst pain possible". Higher scores indicate a worse pain outcome.
Time frame: 2 weeks post-surgery
Number of Remaining Opioid Pills at 2 Weeks Post-Surgery
The physical count of remaining 5 mg oxycodone pills will be reported by the participant via a follow-up phone call to determine final consumption.
Time frame: 2 weeks post-surgery
Number of Participants Experiencing Medication-Related Adverse Effects
The frequency of participants reporting expected adverse events associated with the prescribed multimodal regimens (e.g., gastrointestinal issues for naproxen; liver toxicity concerns for acetaminophen; dizziness, drowsiness, or nausea for oxycodone and gabapentin).
Time frame: Through 2 weeks post-surgery
Number of Remaining Opioid Pills at 3 Days Post-Surgery
The physical count of remaining 5 mg oxycodone pills will be reported by the participant via a follow-up phone call to determine total consumption.
Time frame: 3 days post-surgery
Plan to share: No — Individual participant data will not be made available outside of the primary research team to maintain participant confidentiality. Aggregated summary results will be published and made available on ClinicalTrials.gov as required by law.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Gabapentin