Femoro Acetabular ImpingementPhase 4NCT04114058
A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
A Phase 4 study testing liposomal bupivicaine and Fascia iliaca blockade in people with Femoro Acetabular Impingement, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- liposomal bupivicaine and Fascia iliaca blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (>18 years old)
- diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.
Who cannot join
- patients undergoing revision procedures, bilateral procedures,
- advanced osteoarthritis (<2mm joint space on plain radiographs)
- frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
- diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
- allergy to liposomal bupivicaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy
Read the detailed description
The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- liposomal bupivicaine, Fascia iliaca blockade
- Keywords
- hip arthroscopy
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivicaineDrug
Also called exparel
local field infiltration
Fascia iliaca blockadeProcedure or surgery
fascia iliaca compartment blockade
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivicaine | Active comparator | Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control Receives: Drug: liposomal bupivicaine |
| fascia iliaca blockade | Active comparator | Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Receives: Procedure: Fascia iliaca blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.
Measured: post op days 1-4 (Average VAS score of first 4 days of post op)
Secondary outcomes (2)
Narcotic Utilization
Record of number of narcotic pain pills utilized by patients . This was reported as a total from post op day 1 to 4. The number listed is an average from each patient, from the total pills taken at home.
Measured: total pill taken over the course of days 1-4 post op.
Total Number of at Home Falls.
number of falls occurring at home after discharge. This is the total number of falls of all patients in each group, over the first 7 days post op. This is not reported as a mean.
Measured: Post op days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start29 Oct 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
- Investigators
- Michael Banffy, MD, Principal investigator, Cedars Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114058
- Sponsor's protocol ID
- Pro00056482
- Status last verified
- Apr 2021
- First submitted
- 4 Sep 2019
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
PubMed 28802777Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.
PubMed 24061718
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
- ClinicalTrials.gov ID
- NCT04114058
- Acronym / sponsor ID
- Pro00056482
- Conditions
- Femoro Acetabular Impingement
- Keywords
- hip arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 11 May 2021
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 compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy
Detailed description
The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivicaine | Active comparator | Drug: liposomal bupivicaineFollowing hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control |
| fascia iliaca blockade | Active comparator | Procedure: Fascia iliaca blockadePreoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (>18 years old)
- diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.
Key exclusion criteria (5 listed)
- patients undergoing revision procedures, bilateral procedures,
- advanced osteoarthritis (<2mm joint space on plain radiographs)
- frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
- diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
- allergy to liposomal bupivicaine
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 |
|---|---|---|
| liposomal bupivicaineAlso: exparellocal field infiltration | Drug | Liposomal Bupivicaine |
| Fascia iliaca blockadefascia iliaca compartment blockade | Procedure or surgery | fascia iliaca blockade |
Primary outcome
Visual Analogue Scale
Time frame: post op days 1-4 (Average VAS score of first 4 days of post op)
pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.
2 secondary outcomes
Narcotic Utilization
Time frame: total pill taken over the course of days 1-4 post op.
Total Number of at Home Falls.
Time frame: Post op days 1-7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28802777Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.
- Background: PubMed 24061718Krych AJ, Baran S, Kuzma SA, Smith HM, Johnson RL, Levy BA. Utility of multimodal analgesia with fascia iliaca blockade for acute pain management following hip arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):843-7. doi: 10.1007/s00167-013-2665-y. Epub 2013 Sep 24.
- Individual participant dataSharing planned: No
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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.
Michael Banffy, MD principal investigator
Cedars Sinai
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 liposomal bupivicaine and Fascia iliaca blockade in people with Femoro Acetabular Impingement, run by Cedars-Sinai Medical Center 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 May 2021. 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. 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 11 May 2021). 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?
Visual Analogue Scale (time frame: post op days 1-4 (Average VAS score of first 4 days of post op)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114058, which also lists 2 linked publications.
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 11 May 2021.