Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction, Opioid Consumption
Conditions
Keywords
opioid, gabapentin, Opioid Sparing, Opioid Stewardship, Non-Opioid Analgesics, Oxycodone, Multimodal Analgesia, Postoperative Pain, Upper Extremity Surgery
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: 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.
Interventions
DRUGNaproxen
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.
DRUGAcetaminophen
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.
DRUGoxycodone
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).
DRUGGabapentin
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.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requesting an Additional Postoperative Pain Medication Refill | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery | 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. |
| Number of Remaining Opioid Pills at 3 Days Post-Surgery | 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. |
| Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery | 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. |
| Number of Participants Experiencing Medication-Related Adverse Effects | Through 2 weeks post-surgery | 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). |
| Number of Remaining Opioid Pills at 2 Weeks Post-Surgery | 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. |
Countries
United States
Outcome results
None listed