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

NCT02933671 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00070686
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis; Primary Total Hip Arthroplasty; Pain

Keywords

suprainguinal fascia iliaca (SIFI); nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cumulative Opioid Consumption

  24 hours

• Motor Strength, as Measured by Dynamometry

  4 hours postoperatively

• Numeric Pain Score at 24 Hours, as Measured by NRS 11

  24 hours

• Ambulation, as Measured by Distanced Walked

  post-op day 0

Study Arms (2)

Suprainguinal Fascia Iliaca (SIFI) block

EXPERIMENTAL

A nerve block technique using a numbing medication called ropivacaine.

Procedure: Suprainguinal fascia iliaca (SIFI) block; Drug: Ropivacaine

Sham group

PLACEBO COMPARATOR

The same nerve block technique as above, however using an inactive solution of salt water.

Procedure: Sham block; Drug: Saline

Interventions

Suprainguinal fascia iliaca (SIFI) block PROCEDURE

An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.

Suprainguinal Fascia Iliaca (SIFI) block

Sham block PROCEDURE

An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.

Sham group

Ropivacaine DRUG

Local anesthetic (numbing drug)

Also known as: Naropin

Suprainguinal Fascia Iliaca (SIFI) block

Saline DRUG

Salt water placebo

Also known as: Salt water

Sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• between 18 and 75 years old
• American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Pain

Interventions

Dental Occlusion; Ropivacaine; Sodium Chloride; Fluoridation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Preventive Dentistry; Public Health Dentistry; Environment and Public Health

Results Point of Contact

• Title: W. Michael Bullock, MD, PhD
• Organization: Duke University

william.bullock@duke.edu

919-668-2024

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 14, 2016
• Study Start: August 1, 2017
• Primary Completion: March 16, 2020
• Study Completion: March 17, 2020
• Last Updated: July 19, 2022
• Results First Posted: July 19, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)