Back to resultsSuprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Primary Purpose
Hip Osteoarthritis, Primary Total Hip Arthroplasty, Pain
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Suprainguinal fascia iliaca (SIFI) block
Sham block
Ropivacaine
Saline
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Osteoarthritis focused on measuring suprainguinal fascia iliaca (SIFI), nerve block
Eligibility Criteria
Inclusion Criteria:
- English speaking
- between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty
Exclusion Criteria:
- ASA 4 or 5
- revision hip arthroplasty
- diagnosis of chronic pain
- daily chronic opioid use (over 3 months of continuous opioid use)
- inability to communicate pain scores or need for analgesia
- acute hip fracture
- Infection at the site of block placement
- Age under 18 years old or greater than 75 years old
- Pregnant women
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Sites / Locations
- Duke University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Suprainguinal Fascia Iliaca (SIFI) block
Sham group
Arm Description
A nerve block technique using a numbing medication called ropivacaine.
The same nerve block technique as above, however using an inactive solution of salt water.
Outcomes
Primary Outcome Measures
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
Secondary Outcome Measures
Cumulative Opioid Consumption
Reported in IV morphine equivalents.
Motor Strength, as Measured by Dynamometry
Reported as pounds per square inch (PSI).
Numeric Pain Score at 24 Hours, as Measured by NRS 11
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
Ambulation, as Measured by Distanced Walked
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02933671
Brief Title
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Official Title
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
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
The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Primary Total Hip Arthroplasty, Pain
Keywords
suprainguinal fascia iliaca (SIFI), nerve block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suprainguinal Fascia Iliaca (SIFI) block
Arm Type
Experimental
Arm Description
A nerve block technique using a numbing medication called ropivacaine.
Arm Title
Sham group
Arm Type
Placebo Comparator
Arm Description
The same nerve block technique as above, however using an inactive solution of salt water.
Intervention Type
Procedure
Intervention Name(s)
Suprainguinal fascia iliaca (SIFI) block
Intervention Description
An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
Intervention Type
Procedure
Intervention Name(s)
Sham block
Intervention Description
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Local anesthetic (numbing drug)
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Salt water
Intervention Description
Salt water placebo
Primary Outcome Measure Information:
Title
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
Description
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
Time Frame
4 hours postoperatively
Secondary Outcome Measure Information:
Title
Cumulative Opioid Consumption
Description
Reported in IV morphine equivalents.
Time Frame
24 hours
Title
Motor Strength, as Measured by Dynamometry
Description
Reported as pounds per square inch (PSI).
Time Frame
4 hours postoperatively
Title
Numeric Pain Score at 24 Hours, as Measured by NRS 11
Description
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
Time Frame
24 hours
Title
Ambulation, as Measured by Distanced Walked
Time Frame
post-op day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking
between 18 and 75 years old
American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty
Exclusion Criteria:
ASA 4 or 5
revision hip arthroplasty
diagnosis of chronic pain
daily chronic opioid use (over 3 months of continuous opioid use)
inability to communicate pain scores or need for analgesia
acute hip fracture
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Learn more about this trial
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
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