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Low Dose Dexamethasone for Distal Radius Fractures

Primary Purpose

Post Operative Pain, Distal Radius Fracture

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 4mg
Ropivacaine
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique
  • American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery
  • Opioid naïve patients

Exclusion Criteria:

  • History of Drug/opioid/alcohol abuse
  • Polytrauma patients
  • History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc)
  • Excessive BMI
  • Pregnancy

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: Block with Ropivacaine + Dexamethasone

Group 2: Ropivacaine Block + IV Dexamethasone

Arm Description

Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered

Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously

Outcomes

Primary Outcome Measures

Postoperative pain control
Measured using participants Visual Analog Scale (VAS) pain scores
Postoperative pain control #2 questionnaire
Measured by asking participants how much medication they take after surgery to help control their pain

Secondary Outcome Measures

Full Information

First Posted
March 2, 2022
Last Updated
March 9, 2022
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT05274113
Brief Title
Low Dose Dexamethasone for Distal Radius Fractures
Official Title
Efficacy of Direct Versus Peripheral Low-Dose Adjuvant Dexamethasone on Duration and Rebound Pain in Regional Anesthesia for Distal Radius Fracture Fixation: A Prospective Randomized Controlled Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 10, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Block with Ropivacaine + Dexamethasone
Arm Type
Active Comparator
Arm Description
Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered
Arm Title
Group 2: Ropivacaine Block + IV Dexamethasone
Arm Type
Active Comparator
Arm Description
Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4mg
Intervention Description
4 mg of Dexamethasone will be given before surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ultrasound guided supraclavicular block with ropivacaine will be given to patients before surgery
Primary Outcome Measure Information:
Title
Postoperative pain control
Description
Measured using participants Visual Analog Scale (VAS) pain scores
Time Frame
72 hours
Title
Postoperative pain control #2 questionnaire
Description
Measured by asking participants how much medication they take after surgery to help control their pain
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery Opioid naïve patients Exclusion Criteria: History of Drug/opioid/alcohol abuse Polytrauma patients History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc) Excessive BMI Pregnancy
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Low Dose Dexamethasone for Distal Radius Fractures

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