Optimizing Multimodal Pain Regimens: Evaluating the Analgesic Effect of Pill Quantity and Gabapentin in Reducing Opioid Dependency
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- AdventHealth
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Number of Participants Requesting an Additional Postoperative Pain Medication Refill
Study Overview
Brief Summary
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:
- Does increasing the total physical quantity of non-opioid pills (Naproxen and Acetaminophen) prescribed in smaller individual doses alter a patient's self-reported postoperative pain scores, even when the total daily milligram dosage remains identical?
- Does combining the non-opioid medication gabapentin with a significantly lower initial quantity of prescribed opioid pills (oxycodone) provide comparable pain relief and reduce the rate of subsequent medication refill requests?
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:
- Be randomized into one of three standard postoperative pain medication groups varying in non-opioid pill counts or featuring a shortened opioid course combined with gabapentin.
- Report their pain scores, medication adverse effects, and any prescription refill requests during follow-up phone calls at 3 days and 2 weeks post-surgery.
- Track and report the remaining number of opioid pills they have left at the time of the follow-up calls.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years old
- •Able to read, write and understand English
- •Undergoing hand, wrist, or elbow surgery
Exclusion Criteria
- •Inpatient surgery
- •Patients with a history of illicit substance use/abuse, patients that were prescribed codeine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, or oxymorphone.
- •Allergy or intolerance of NSAIDS, acetaminophen, gabapentin, or narcotics.
Arms & Interventions
Standard Low-Volume Regimen
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).
Intervention: oxycodone (Drug)
Gabapentin Multimodal & Reduced Opioid Regimen
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).
Intervention: oxycodone (Drug)
Gabapentin Multimodal & Reduced Opioid Regimen
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).
Intervention: Gabapentin (Drug)
High Pill-Count Multimodal Regimen
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).
Intervention: oxycodone (Drug)
High Pill-Count Multimodal Regimen
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).
Intervention: Naproxen (Drug)
High Pill-Count Multimodal Regimen
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).
Intervention: Acetaminophen (Drug)
Standard Low-Volume Regimen
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).
Intervention: Naproxen (Drug)
Standard Low-Volume Regimen
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).
Intervention: Acetaminophen (Drug)
Gabapentin Multimodal & Reduced Opioid Regimen
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).
Intervention: Naproxen (Drug)
Gabapentin Multimodal & Reduced Opioid Regimen
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).
Intervention: Acetaminophen (Drug)
Outcomes
Primary Outcomes
Number of Participants Requesting an Additional Postoperative Pain Medication Refill
Time Frame: Through 2 weeks post-surgery
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.
Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery
Time Frame: 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.
Secondary Outcomes
- Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery(2 weeks post-surgery)
- Number of Remaining Opioid Pills at 3 Days Post-Surgery(3 days post-surgery)
- Number of Participants Experiencing Medication-Related Adverse Effects(Through 2 weeks post-surgery)
- Number of Remaining Opioid Pills at 2 Weeks Post-Surgery(2 weeks post-surgery)
- Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery(3 days post-surgery)