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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Hip Osteoarthritis; Primary Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Suprainguinal fascia iliaca (SIFI) block; Drug: Ropivacaine; Procedure: Sham block; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suprainguinal Fascia Iliaca (SIFI) block; A nerve block technique using a numbing medication called ropivacaine.	Procedure: Suprainguinal fascia iliaca (SIFI) block; An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.; Drug: Ropivacaine; Local anesthetic (numbing drug); Other Names: Naropin
Placebo Comparator: Sham group; The same nerve block technique as above, however using an inactive solution of salt water.	Procedure: Sham block; An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.; Drug: Saline; Salt water placebo; Other Names: Salt water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Consumption	Reported in IV morphine equivalents.	24 hours
Motor Strength, as Measured by Dynamometry	Reported as pounds per square inch (PSI).	4 hours postoperatively
Numeric Pain Score at 24 Hours, as Measured by NRS 11	The NRS 11 ranges from 0 (no pain) to 10 (intense pain).	24 hours
Ambulation, as Measured by Distanced Walked		post-op day 0

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 17, 2020

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: suprainguinal fascia iliaca (SIFI); nerve block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Pro00070686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Drug and device information, study documents

• 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