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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02933671
• Other study ID #: Pro00070686
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: March 17, 2020

Study information

• Verified date: June 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 17, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip
• Pain
• Primary Total Hip Arthroplasty

Intervention

Procedure:
• Suprainguinal fascia iliaca (SIFI) block
An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
• Sham block
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.

Drug:
• Ropivacaine
Local anesthetic (numbing drug)
• Saline
Salt water placebo

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative Opioid Consumption	Reported in IV morphine equivalents.	24 hours
Secondary	Motor Strength, as Measured by Dynamometry	Reported as pounds per square inch (PSI).	4 hours postoperatively
Secondary	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
Secondary	Ambulation, as Measured by Distanced Walked		post-op day 0