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

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Duke University

Status and phase

Terminated
Phase 4

Conditions

Hip Osteoarthritis
Primary Total Hip Arthroplasty
Pain

Treatments

Procedure: Suprainguinal fascia iliaca (SIFI) block
Drug: Saline
Procedure: Sham block
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02933671
Pro00070686

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

11 participants in 2 patient groups, including a placebo group

Suprainguinal Fascia Iliaca (SIFI) block
Experimental group
Description:
A nerve block technique using a numbing medication called ropivacaine.
Treatment:
Drug: Ropivacaine
Procedure: Suprainguinal fascia iliaca (SIFI) block
Sham group
Placebo Comparator group
Description:
The same nerve block technique as above, however using an inactive solution of salt water.
Treatment:
Procedure: Sham block
Drug: Saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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