NCT05215236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

January 18, 2022

Last Update Submit

September 30, 2025

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (3)

  • Oral Morphine Equivalent

    opiate pill count

    postoperative day to two week visit

  • Oral Morphine Equivalent

    opiate pill count

    two week to six week visit

  • Oral Morphine Equivalent

    opiate pill count

    six week to twelve week visit

Secondary Outcomes (3)

  • Visual Analog Score

    postoperative day to two week visit

  • Visual Analog Score

    six week visit

  • Visual Analog Score

    twelve week visit

Other Outcomes (6)

  • Incidence of treatment-emergent adverse event

    postoperative day to two week visit

  • Incidence of treatment-emergent adverse event

    two week to six week visit

  • Incidence of treatment-emergent adverse event

    six week to twelve week visit

  • +3 more other outcomes

Study Arms (2)

Opiate Sparing

EXPERIMENTAL

Standard 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

Other: Opiate Sparing

Opiate Based

ACTIVE COMPARATOR

Standard 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

Other: Opiate Based

Interventions

Opiate SparingOTHER

Subjects will receive non-opiate medications for pain control

Opiate Sparing
Opiate BasedOTHER

Subjects will receive opiate based medications for pain control

Opiate Based

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (7)

  • 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.

    PMID: 26869374BACKGROUND

  • 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.

    PMID: 31733939BACKGROUND

  • 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.

    PMID: 33552691BACKGROUND

  • 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.

    PMID: 28235120BACKGROUND

  • 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.

    PMID: 31311667BACKGROUND

  • 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.

    PMID: 29406338BACKGROUND

  • 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.

    PMID: 30747964BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • William J Weller, MD

    Campbell Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

March 1, 2022

Primary Completion

May 31, 2024

Study Completion

June 30, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)