TerminatedNCT02933671Updated Jul 19, 2022Results posted

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

A Phase 4 interventional study of Suprainguinal fascia iliaca (SIFI) block and Sham block in Hip Osteoarthritis, Primary Total Hip Arthroplasty and Pain, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Duke University · Phase 4, Interventional, and Supportive care

Why this study was terminated

Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.

Phase: Phase 4
Study type: Interventional
Enrollment: 11
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Hip Osteoarthritis
Primary Total Hip Arthroplasty
Pain

Browse trials for

Osteoarthritis, Hip 628

Keywords

suprainguinal fascia iliaca (SIFI)
nerve block

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 11 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 11 participants (actual)

Study arms

Experimental
Suprainguinal Fascia Iliaca (SIFI) block
A nerve block technique using a numbing medication called ropivacaine.
Procedure: Suprainguinal fascia iliaca (SIFI) block · Drug: Ropivacaine
Placebo comparator
Sham group
The same nerve block technique as above, however using an inactive solution of salt water.
Procedure: Sham block · Drug: Saline

Interventions

ProcedureSuprainguinal fascia iliaca (SIFI) block
An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
ProcedureSham block
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
DrugRopivacaine
Local anesthetic (numbing drug)
Also known as: Naropin
DrugSaline
Salt water placebo
Also known as: Salt water

What researchers measure

Primary outcomes

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).
Time frame: 4 hours postoperatively

Secondary outcomes

Cumulative Opioid Consumption
Reported in IV morphine equivalents.
Time frame: 24 hours
Motor Strength, as Measured by Dynamometry
Reported as pounds per square inch (PSI).
Time frame: 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).
Time frame: 24 hours
Ambulation, as Measured by Distanced Walked
Time frame: post-op day 0

Results

Posted Jul 19, 2022

Participant flow

Participant flow — Overall Study
Milestone	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Started	5	5
Completed	5	5
Not completed	0	0

Outcome measures

PrimaryNumeric 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).

Time frame:: 4 hours postoperatively
Reported as:: Mean · score on a scale

Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
score on a scale	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11	2.4 ± 1.14	5.4 ± 1.95

SecondaryCumulative Opioid Consumption

Reported in IV morphine equivalents.

Time frame:: 24 hours
Reported as:: Mean · IV morphine equivalents in mg

Cumulative Opioid Consumption
IV morphine equivalents in mg	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Cumulative Opioid Consumption	33.8 ± 24.0	41.9 ± 29.3

SecondaryMotor Strength, as Measured by Dynamometry

Reported as pounds per square inch (PSI).

Time frame:: 4 hours postoperatively
Reported as:: Mean · PSI

Motor Strength, as Measured by Dynamometry
PSI	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Motor Strength, as Measured by Dynamometry	28.7 ± 14.8	19.7 ± 22.8

SecondaryNumeric Pain Score at 24 Hours, as Measured by NRS 11

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

Time frame:: 24 hours
Reported as:: Mean · score on a scale

Numeric Pain Score at 24 Hours, as Measured by NRS 11
score on a scale	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Numeric Pain Score at 24 Hours, as Measured by NRS 11	2.6 ± 1.9	5.2 ± 1.3

SecondaryAmbulation, as Measured by Distanced Walked

Time frame:: post-op day 0
Reported as:: Mean · feet

Ambulation, as Measured by Distanced Walked
feet	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Ambulation, as Measured by Distanced Walked	99.6 ± 122.2	20.8 ± 44.3

Adverse events

Collected over 24 hours from time of block. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Suprainguinal Fascia Iliaca (SIFI) Block	0/5 (0%)	0/5 (0%)	0/5 (0%)
Sham Group	0/5 (0%)	0/5 (0%)	1/5 (20%)

Most frequent other events

Most frequent other events
Event	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group
Motor weakness in the quadriceps and adductor group musclesMusculoskeletal and connective tissue disorders	0/5	1/5

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group	Total
Mean	63.8 ± 6.0	51.6 ± 17.8	57.7 ± 14.1

Sex: Female, Male
Sex: Female, Male(Participants)	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group	Total
Female	0	1	1
Male	5	4	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	5	5	10
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	5	4	9
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Suprainguinal Fascia Iliaca (SIFI) Block	Sham Group	Total
United States	5	5	10

Study locations

1 site

Duke University Hospital
Durham, North Carolina 27713, United States

References and documents

Study documents

Protocol and statistical analysis plan · Dec 11, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02933671
Lead sponsor: Duke University
Responsible party: Sponsor
First posted: Oct 14, 2016
Start date: Aug 1, 2017
Primary completion: Mar 16, 2020
Completion: Mar 17, 2020
Results posted: Jul 19, 2022
Last update: Jul 19, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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