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Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

Phase 4
Terminated
Conditions
Hip Osteoarthritis
Pain
Primary Total Hip Arthroplasty
Interventions
Procedure: Sham block
Procedure: Suprainguinal fascia iliaca (SIFI) block
Drug: Saline
Registration Number
NCT02933671
Lead Sponsor
Duke University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
11
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham groupSham blockThe same nerve block technique as above, however using an inactive solution of salt water.
Suprainguinal Fascia Iliaca (SIFI) blockSuprainguinal fascia iliaca (SIFI) blockA nerve block technique using a numbing medication called ropivacaine.
Sham groupSalineThe same nerve block technique as above, however using an inactive solution of salt water.
Suprainguinal Fascia Iliaca (SIFI) blockRopivacaineA nerve block technique using a numbing medication called ropivacaine.
Primary Outcome Measures
NameTimeMethod
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 114 hours postoperatively

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Secondary Outcome Measures
NameTimeMethod
Motor Strength, as Measured by Dynamometry4 hours postoperatively

Reported as pounds per square inch (PSI).

Numeric Pain Score at 24 Hours, as Measured by NRS 1124 hours

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Cumulative Opioid Consumption24 hours

Reported in IV morphine equivalents.

Ambulation, as Measured by Distanced Walkedpost-op day 0

Trial Locations

Locations (1)

Duke University Hospital

🇺🇸

Durham, North Carolina, United States

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