Hip OsteoarthritisPhase 4NCT02933671
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
A Phase 4 study testing Suprainguinal fascia iliaca (SIFI) block, Ropivacaine and Saline in people with Hip Osteoarthritis and Primary Total Hip Arthroplasty, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Osteoarthritis, Primary Total Hip Arthroplasty, Pain
- What is being tested?
- Suprainguinal fascia iliaca (SIFI) block, Ropivacaine and Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 17 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27713
About this study
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
- Being tested
- Suprainguinal fascia iliaca (SIFI) block, Sham block, Ropivacaine, Saline
- Keywords
- suprainguinal fascia iliaca (SIFI), nerve block
- Medical subject headings
- Osteoarthritis, Hip, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprainguinal fascia iliaca (SIFI) blockProcedure or surgery
An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
Sham blockProcedure or surgery
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
RopivacaineDrug
Also called Naropin
Local anesthetic (numbing drug)
SalineDrug
Also called Salt water
Salt water placebo
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) block | Experimental | A nerve block technique using a numbing medication called ropivacaine. Receives: 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. Receives: Procedure: Sham block; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 hours postoperatively
Secondary outcomes (4)
Cumulative Opioid Consumption
Reported in IV morphine equivalents.
Measured: 24 hours
Motor Strength, as Measured by Dynamometry
Reported as pounds per square inch (PSI).
Measured: 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).
Measured: 24 hours
Ambulation, as Measured by Distanced Walked
Measured: post-op day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start1 Aug 2017
- Primary completion16 Mar 2020
- Study completion17 Mar 2020
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933671
- Sponsor's protocol ID
- Pro00070686
- Status last verified
- Jun 2022
- First submitted
- 30 Sep 2016
- Last updated
- 19 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02933671
- Acronym / sponsor ID
- Pro00070686
- Conditions
- Hip Osteoarthritis, Primary Total Hip Arthroplasty, Pain
- Keywords
- suprainguinal fascia iliaca (SIFI), nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving any intervention.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal Fascia Iliaca (SIFI) block | Experimental | Procedure: Suprainguinal fascia iliaca (SIFI) block, Drug: RopivacaineA nerve block technique using a numbing medication called ropivacaine. |
| Sham group | Placebo comparator | Procedure: Sham block, Drug: SalineThe same nerve block technique as above, however using an inactive solution of salt water. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprainguinal fascia iliaca (SIFI) blockAn ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine. | Procedure or surgery | Suprainguinal Fascia Iliaca (SIFI) block |
| Sham blockAn ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. | Procedure or surgery | Sham group |
| RopivacaineAlso: NaropinLocal anesthetic (numbing drug) | Drug | Suprainguinal Fascia Iliaca (SIFI) block |
| SalineAlso: Salt waterSalt water placebo | Drug | Sham group |
Primary outcome
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
Time frame: 4 hours postoperatively
The NRS 11 ranges from 0 (no pain) to 10 (intense pain).
4 secondary outcomes
Cumulative Opioid Consumption
Time frame: 24 hours
Motor Strength, as Measured by Dynamometry
Time frame: 4 hours postoperatively
Numeric Pain Score at 24 Hours, as Measured by NRS 11
Time frame: 24 hours
Ambulation, as Measured by Distanced Walked
Time frame: post-op day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suprainguinal fascia iliaca (SIFI) block, Ropivacaine and Saline in people with Hip Osteoarthritis and Primary Total Hip Arthroplasty, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11 (time frame: 4 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.