Opioid Abuse (Disorder)Phase 4NCT07750639
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill Quantity
A Phase 4 study testing Naproxen, Acetaminophen and oxycodone in people with Opioid Abuse (Disorder) and Opioid Analgesia, run by AdventHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction
- What is being tested?
- Naproxen, Acetaminophen and oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- Able to read, write and understand English
- Undergoing hand, wrist, or elbow surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Multimodal Pain Regimens: Evaluating the Analgesic Effect of Pill Quantity and Gabapentin in Reducing Opioid Dependency
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?
Read more
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.
Read the 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.
- Conditions
- Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction, Opioid Consumption
- Being tested
- Naproxen, Acetaminophen, oxycodone, Gabapentin
- Keywords
- opioid, gabapentin, Opioid Sparing, Opioid Stewardship, Non-Opioid Analgesics, Oxycodone, Multimodal Analgesia, Postoperative Pain, Upper Extremity Surgery
- Medical subject headings
- Opioid-Related Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
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.
AcetaminophenDrug
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.
oxycodoneDrug
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).
GabapentinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| High Pill-Count Multimodal Regimen | Experimental | 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). Receives: Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone |
| Standard Low-Volume Regimen | Active comparator | 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). Receives: Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone |
| Gabapentin Multimodal & Reduced Opioid Regimen | Experimental | 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). Receives: Drug: Naproxen; Drug: Acetaminophen; Drug: oxycodone; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 2 weeks post-surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 3 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2024
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Kachooei, MD PhD, Principal investigator, Rothman Orthopedics at AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750639
- Sponsor's protocol ID
- 2138972
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Multimodal Pain Regimens: Evaluating the Analgesic Effect of Pill Quantity and Gabapentin in Reducing Opioid Dependency
- ClinicalTrials.gov ID
- NCT07750639
- Acronym / sponsor ID
- 2138972
- Conditions
- Opioid Abuse (Disorder), Opioid Analgesia, Opioid Analgesic Adverse Reaction, Opioid Consumption
- Keywords
- opioid, gabapentin, Opioid Sparing, Opioid Stewardship, Non-Opioid Analgesics, Oxycodone, Multimodal Analgesia, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Pill-Count Multimodal Regimen | Experimental | Drug: Naproxen, Drug: Acetaminophen, Drug: oxycodoneParticipants 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). |
| Standard Low-Volume Regimen | Active comparator | Drug: Naproxen, Drug: Acetaminophen, Drug: oxycodoneParticipants 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). |
| Gabapentin Multimodal & Reduced Opioid Regimen | Experimental | Drug: Naproxen, Drug: Acetaminophen, Drug: oxycodone, Drug: GabapentinParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old
- Able to read, write and understand English
- Undergoing hand, wrist, or elbow surgery
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaproxenAn 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. | Drug | Gabapentin Multimodal & Reduced Opioid Regimen, High Pill-Count Multimodal Regimen, Standard Low-Volume Regimen |
| AcetaminophenAn 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. | Drug | Gabapentin Multimodal & Reduced Opioid Regimen, High Pill-Count Multimodal Regimen, Standard Low-Volume Regimen |
| oxycodoneAn 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). | Drug | Gabapentin Multimodal & Reduced Opioid Regimen, High Pill-Count Multimodal Regimen, Standard Low-Volume Regimen |
| GabapentinAn 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. | Drug | Gabapentin Multimodal & Reduced Opioid Regimen |
Primary outcome
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.
5 secondary outcomes
Postoperative Pain Score on the Visual Analog Scale (VAS) at 3 Days Post-Surgery
Time frame: 3 days post-surgery
Postoperative Pain Score on the Visual Analog Scale (VAS) at 2 Weeks Post-Surgery
Time frame: 2 weeks post-surgery
Number of Remaining Opioid Pills at 2 Weeks Post-Surgery
Time frame: 2 weeks post-surgery
Number of Participants Experiencing Medication-Related Adverse Effects
Time frame: Through 2 weeks post-surgery
Number of Remaining Opioid Pills at 3 Days Post-Surgery
Time frame: 3 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amir Kachooei, MD PhD principal investigator
Rothman Orthopedics at AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen, Acetaminophen and oxycodone in people with Opioid Abuse (Disorder) and Opioid Analgesia, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requesting an Additional Postoperative Pain Medication Refill (time frame: Through 2 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.