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Distal Radius FractureNCT05215236

Opiate Sparing Protocol Randomized Controlled Trial in Open Distal Radius Fracture Repair

A study testing Opiate Sparing and Opiate Based in people with Distal Radius Fracture, run by Campbell Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A comparison of oral morphine equivalents between an opiate sparing cohort and an opiate based cohort following open reduction internal fixation of a distal radius fracture. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Distal Radius Fracture
What is being tested?
Opiate Sparing and Opiate Based
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Open reduction internal fixation surgery at Campbell Clinic Surgery Center
  • Body Mass Index less than or equal to 45
  • Fluent in verbal and written English

Who cannot join

  • Known sensitivity to medications in either protocol
  • Renal disease by medical history
  • Concomitant ipsilateral upper extremity injury or condition other than wrist
  • Chronic pain syndrome
  • Consumption of ten consecutive day so opioid use in the previous 90 days
  • Worker's compensation
  • Women who are pregnant, planning to become pregnant, or are breastfeeding
  • Takes either angiotensin-converting enzyme inhibitor or angiotensin II receptor blockers for hypertension

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Campbell Clinic

    Germantown, Tennessee, 38138

Other trials in United States

About this study

Official title: Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate Based Protocol Following Open Reduction Internal Fixation of Distal Radius Fractures

A comparison of oral morphine equivalents between an opiate sparing cohort and an opiate based cohort following open reduction internal fixation of a distal radius fracture.

Read the detailed description

Recently, the opioid epidemic has been the center of focus for healthcare providers and governmental agencies due to rising rates of opioid abuse, opioid-related fatalities, and overall economic burden of treating the opioid epidemic. The prescribing patterns of opioid pain medications have fallen under scrutiny and healthcare providers have sought alternative pain management strategies that have limited opioid pain medication use. As orthopaedic surgeons account for 7.7% of all dispensed opioid prescriptions within the United States, surgeons have investigated multimodal pain management strategies to assess effectiveness in controlling postoperative pain as well as limiting opioid use and opioid related complications. The literature documents the safety and effectiveness of non-steroid anti-inflammatory drugs (NSAID) and acetaminophen in soft tissue hand procedures and distal radius fracture plating. Currently, there remains no clear consensus on the ideal pain management strategy following open reduction internal fixation (ORIF) of distal radius fractures and the vast majority of strategies are based on opiate-driven protocols. This study will investigate the effectiveness of an opiate sparing protocol following open reduction and internal fixation (ORIF) of distal radius fractures on opiate consumption as measured by oral morphine equivalents at the 2, 6 and 12 week postoperative time point through collection of pill counts. Secondary outcomes are pain scores, patient satisfaction, and safety reporting (complications, reoperations, and readmissions) during the 12-week episode-of-care. This study will document the safety and effectiveness of an opiate sparing, multimodal pain management protocol in properly selected patients undergoing ORIF of distal radius fractures.

Following written consent documentation, Subjects will be randomized to either the opiate sparing cohort or the opiate based cohort at a 1:1 randomization. No blinding will occur as part of the study.

Being tested
Opiate Sparing, Opiate Based
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opiate SparingOther

    Subjects will receive non-opiate medications for pain control

  • Opiate BasedOther

    Subjects will receive opiate based medications for pain control

Study groups in NCT05215236
Study groupRoleWhat they receive
Opiate SparingExperimentalStandard icing and elevation therapy Acetaminophen 1000 milligrams by mouth every 8 hours for five days then as needed every 8 hours for pain control Gabapentin 100 milligrams by mouth three times per day for 14 days Celecoxib 100 milligrams by mouth two times per day for 5 days Esomeprazole 20 milligrams by mouth once per day for 14 days Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone Oxycodone 5 milligrams by mouth every 6 hours as needed for pain control unresponsive to other medications
Receives: Other: Opiate Sparing
Opiate BasedActive comparatorStandard icing and elevation therapy Oxycodone 5-10 milligrams by mouth every 4 to 6 hours as needed for pain control Acetaminophen 1000 milligrams by mouth every 8 hours as needed for pain control Promethazine 12.5 milligrams by mouth every 8 hours as needed for nausea or vomiting Docusate 100 milligrams by mouth two times per day while taking oxycodone
Receives: Other: Opiate Based

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral Morphine Equivalent

    opiate pill count

    Measured: postoperative day to two week visit

  2. Oral Morphine Equivalent

    opiate pill count

    Measured: two week to six week visit

  3. Oral Morphine Equivalent

    opiate pill count

    Measured: six week to twelve week visit

Secondary outcomes (3)

  1. Visual Analog Score

    Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain

    Measured: postoperative day to two week visit

  2. Visual Analog Score

    Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain

    Measured: six week visit

  3. Visual Analog Score

    Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain

    Measured: twelve week visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start1 Mar 2022
  3. Primary completion31 May 2024
  4. Study completion30 Jun 2025

Resources

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 N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215236
Sponsor's protocol ID
21-08332-FB
Status last verified
Sep 2025
First submitted
18 Jan 2022
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.

    PubMed 26869374

  • Martinez L, Ekman E, Nakhla N. Perioperative Opioid-sparing Strategies: Utility of Conventional NSAIDs in Adults. Clin Ther. 2019 Dec;41(12):2612-2628. doi: 10.1016/j.clinthera.2019.10.002. Epub 2019 Nov 14.

    PubMed 31733939

  • Niedermeier SR, Crouser N, Hidden K, Jain SA. Pain Management following Open Reduction and Internal Fixation of Distal Radius Fractures. J Wrist Surg. 2021 Feb;10(1):27-30. doi: 10.1055/s-0040-1716508. Epub 2020 Oct 14.

    PubMed 33552691

  • O'Neil JT, Wang ML, Kim N, Maltenfort M, Ilyas AM. Prospective Evaluation of Opioid Consumption After Distal Radius Fracture Repair Surgery. Am J Orthop (Belle Mead NJ). 2017 Jan/Feb;46(1):E35-E40.

    PubMed 28235120

  • Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.

    PubMed 31311667

  • Sabatino MJ, Kunkel ST, Ramkumar DB, Keeney BJ, Jevsevar DS. Excess Opioid Medication and Variation in Prescribing Patterns Following Common Orthopaedic Procedures. J Bone Joint Surg Am. 2018 Feb 7;100(3):180-188. doi: 10.2106/JBJS.17.00672.

    PubMed 29406338

  • Thybo KH, Hagi-Pedersen D, Dahl JB, Wetterslev J, Nersesjan M, Jakobsen JC, Pedersen NA, Overgaard S, Schroder HM, Schmidt H, Bjorck JG, Skovmand K, Frederiksen R, Buus-Nielsen M, Sorensen CV, Kruuse LS, Lindholm P, Mathiesen O. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial. JAMA. 2019 Feb 12;321(6):562-571. doi: 10.1001/jama.2018.22039.

    PubMed 30747964

Questions about this trial

What is this clinical trial studying?

A study testing Opiate Sparing and Opiate Based in people with Distal Radius Fracture, run by Campbell Clinic 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 8 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: finished, as of the sponsor's last update on 6 Oct 2025. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Oral Morphine Equivalent (time frame: postoperative day to two week visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215236, which also lists 7 linked publications.

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 6 Oct 2025.

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