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Completed

NCT Number: NCT05215236

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campbell Clinic

Germantown, Tennessee, 38138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Opiate Sparing

Other

Subjects will receive non-opiate medications for pain control

Opiate Based

Other

Subjects will receive opiate based medications for pain control

Primary outcomes

  1. Oral Morphine Equivalent

    Time frame: postoperative day to two week visit

    opiate pill count

  2. Oral Morphine Equivalent

    Time frame: two week to six week visit

    opiate pill count

  3. Oral Morphine Equivalent

    Time frame: six week to twelve week visit

    opiate pill count

Secondary outcomes

  1. Visual Analog Score

    Time frame: postoperative day to two week visit

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

  2. Visual Analog Score

    Time frame: six week visit

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

  3. Visual Analog Score

    Time frame: twelve week visit

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

Other outcomes

  1. Incidence of treatment-emergent adverse event

    Time frame: postoperative day to two week visit

    monitoring for safety events

  2. Incidence of treatment-emergent adverse event

    Time frame: two week to six week visit

    monitoring for safety events

  3. Incidence of treatment-emergent adverse event

    Time frame: six week to twelve week visit

    monitoring for safety events

  4. Patient satisfaction Score

    Time frame: postoperative day to two week visit

    patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied

  5. Patient satisfaction Score

    Time frame: two week to six week visit

    patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied

  6. Patient satisfaction Score

    Time frame: six week to twelve week visit

    patient reported satisfaction with pain management from 0 to 10 where 0 is very unsatisfied and 10 is very satisfied

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 31, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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