NCT02933671

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

Terminated Phase 4 Results posted Last updated 19 July 2022

What this trial tests

Phase 4 trial testing Suprainguinal fascia iliaca (SIFI) block in Hip Osteoarthritis in 11 participants. Terminated before completion.

Timeline

1 August 2017

Primary endpoint
16 March 2020

17 March 2020

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	11
Start date	1 August 2017
Primary completion	16 March 2020
Estimated completion	17 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Suprainguinal fascia iliaca (SIFI) block
• Sham block — full drug profile →
• Ropivacaine (ROPIVACAINE) — full drug profile →
• Saline

Conditions studied

• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
• Primary Total Hip Arthroplasty — all drugs for Primary Total Hip Arthroplasty →
• Pain — all drugs for Pain →

Sponsor

Duke University

Who can join

Adults 18 to 75, any sex, with Hip Osteoarthritis or Primary Total Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 Primary · 4 hours postoperatively

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Group	Value	95% CI
Suprainguinal Fascia Iliaca (SIFI) Block	2.4	± 1.14
Sham Group	5.4	± 1.95

Cumulative Opioid Consumption Secondary · 24 hours

Reported in IV morphine equivalents.

Group	Value	95% CI
Suprainguinal Fascia Iliaca (SIFI) Block	33.8	± 24.0
Sham Group	41.9	± 29.3

Motor Strength, as Measured by Dynamometry Secondary · 4 hours postoperatively

Reported as pounds per square inch (PSI).

Group	Value	95% CI
Suprainguinal Fascia Iliaca (SIFI) Block	28.7	± 14.8
Sham Group	19.7	± 22.8

Numeric Pain Score at 24 Hours, as Measured by NRS 11 Secondary · 24 hours

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Group	Value	95% CI
Suprainguinal Fascia Iliaca (SIFI) Block	2.6	± 1.9
Sham Group	5.2	± 1.3

Ambulation, as Measured by Distanced Walked Secondary · post-op day 0

Group	Value	95% CI
Suprainguinal Fascia Iliaca (SIFI) Block	99.6	± 122.2
Sham Group	20.8	± 44.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours from time of block. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Suprainguinal Fascia Iliaca (SIFI) Block

Serious: 0/5 (0%)

Deaths: 0/5

Sham Group

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (1 terms — click to expand)

Reaction	System	Suprainguinal Fascia Iliac…	Sham Group
Motor weakness in the quadriceps and adductor group muscles	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT02933671 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.