Hip Osteoarthritis, Pain, Primary Total Hip Arthroplasty
Conditions
Keywords
suprainguinal fascia iliaca (SIFI), nerve block
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.
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)
DRUGSaline
Salt water placebo
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | 4 hours postoperatively | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Opioid Consumption | 24 hours | Reported in IV morphine equivalents. |
| Motor Strength, as Measured by Dynamometry | 4 hours postoperatively | Reported as pounds per square inch (PSI). |
| Numeric Pain Score at 24 Hours, as Measured by NRS 11 | 24 hours | The NRS 11 ranges from 0 (no pain) to 10 (intense pain). |
| Ambulation, as Measured by Distanced Walked | post-op day 0 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block A nerve block technique using a numbing medication called ropivacaine.
Suprainguinal fascia iliaca (SIFI) block: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug) | 5 |
| Sham Group The same nerve block technique as above, however using an inactive solution of salt water.
Sham block: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Saline: Salt water placebo | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Suprainguinal Fascia Iliaca (SIFI) Block | Total | Sham Group |
|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 6 | 57.7 years STANDARD_DEVIATION 14.1 | 51.6 years STANDARD_DEVIATION 17.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 10 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants |
| Region of Enrollment United States | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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).
Time frame: 4 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block | Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | 2.4 score on a scale | Standard Deviation 1.14 |
| Sham Group | Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 | 5.4 score on a scale | Standard Deviation 1.95 |
Secondary
Ambulation, as Measured by Distanced Walked
Time frame: post-op day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block | Ambulation, as Measured by Distanced Walked | 99.6 feet | Standard Deviation 122.2 |
| Sham Group | Ambulation, as Measured by Distanced Walked | 20.8 feet | Standard Deviation 44.3 |
Secondary
Cumulative Opioid Consumption
Reported in IV morphine equivalents.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block | Cumulative Opioid Consumption | 33.8 IV morphine equivalents in mg | Standard Deviation 24 |
| Sham Group | Cumulative Opioid Consumption | 41.9 IV morphine equivalents in mg | Standard Deviation 29.3 |
Secondary
Motor Strength, as Measured by Dynamometry
Reported as pounds per square inch (PSI).
Time frame: 4 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block | Motor Strength, as Measured by Dynamometry | 28.7 PSI | Standard Deviation 14.8 |
| Sham Group | Motor Strength, as Measured by Dynamometry | 19.7 PSI | Standard Deviation 22.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) Block | Numeric Pain Score at 24 Hours, as Measured by NRS 11 | 2.6 score on a scale | Standard Deviation 1.9 |
| Sham Group | Numeric Pain Score at 24 Hours, as Measured by NRS 11 | 5.2 score on a scale | Standard Deviation 1.3 |