Back to resultsFascia Iliaca Compartment Blocks for Pain Control in Hip Fractures
Primary Purpose
Hip Fractures
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- Aged 50 or older, low energy hip fracture, acute hip fracture
Exclusion Criteria:
- On anticoagulants, hardware present near injection site, preexisting nerve injury.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non nerve block
Nerve block
Arm Description
Receives no nerve block
Receives nerve block
Outcomes
Primary Outcome Measures
Mean Baseline Pain score on Visual analogue scale at initial encounter
pain is measured 1-10, 1 being the lowest and 10 being the highest
Mean Change from baseline pain score on the visual analogue scale
pain is measured 1-10, 1 being the lowest and 10 being the highest
Secondary Outcome Measures
Full Information
NCT ID
NCT04086914
First Posted
September 10, 2019
Last Updated
February 4, 2020
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04086914
Brief Title
Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures
Official Title
Fascia Iliaca Compartment Blocks to Improve Preoperative Pain Control in Elderly Hip Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn at PI's request. no patients enrolled.
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is comparing the use of a peripheral nerve block and standard opioid pain medications in pain control in hip fractures prior to surgery. A peripheral nerve block is a procedure that injects numbing medicine around a nerve to help decrease the pain, motion, and sensation around the painful site temporarily. The purpose of this study is to evaluate if peripheral nerve blocks are more effective for pain control than just standard opioid pain medication while decreasing the amount of side effects from opioid medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non nerve block
Arm Type
No Intervention
Arm Description
Receives no nerve block
Arm Title
Nerve block
Arm Type
Experimental
Arm Description
Receives nerve block
Intervention Type
Procedure
Intervention Name(s)
Nerve Block
Intervention Description
This group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone.
Primary Outcome Measure Information:
Title
Mean Baseline Pain score on Visual analogue scale at initial encounter
Description
pain is measured 1-10, 1 being the lowest and 10 being the highest
Time Frame
0-60 minutes
Title
Mean Change from baseline pain score on the visual analogue scale
Description
pain is measured 1-10, 1 being the lowest and 10 being the highest
Time Frame
3-8 hours after initial encounter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 50 or older, low energy hip fracture, acute hip fracture
Exclusion Criteria:
On anticoagulants, hardware present near injection site, preexisting nerve injury.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33238043
Citation
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Results Reference
derived
Learn more about this trial
Fascia Iliaca Compartment Blocks for Pain Control in Hip Fractures
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