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

NCT ID: NCT02933671

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-03-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Suprainguinal Fascia Iliaca (SIFI) block

A nerve block technique using a numbing medication called ropivacaine.

Group Type: EXPERIMENTAL

Suprainguinal fascia iliaca (SIFI) block

Intervention Type: PROCEDURE

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

Ropivacaine

Intervention Type: DRUG

Local anesthetic (numbing drug)

Sham group

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

Group Type: PLACEBO_COMPARATOR

Sham block

Intervention Type: PROCEDURE

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

Saline

Intervention Type: DRUG

Salt water placebo

Interventions

Suprainguinal fascia iliaca (SIFI) block

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

Intervention Type: PROCEDURE

Sham block

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

Intervention Type: PROCEDURE

Ropivacaine

Local anesthetic (numbing drug)

Intervention Type: DRUG

Saline

Salt water placebo

Intervention Type: DRUG

Other Intervention Names

Naropin; Salt water

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00070686

Identifier Type: -

Identifier Source: org_study_id