Femoroacetabular ImpingementNCT02674113
Regional Anesthesia in Hip Arthroscopy
A study testing regional anesthesia bupivacaine in people with Femoroacetabular Impingement, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- regional anesthesia bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
- Age 18-45 years old
- Not pregnant
- No history of neuropathic pain
- No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
- Willing and able to comply with post-operative hip arthroscopy protocol
- No documented allergy to anesthetic agents
- Able to attend follow up appointments
Who cannot join
- Allergy to regional anesthetic
- Age <18 or >45 years
- Pregnant females
- History of neuropathic pain
- Radiographic signs of osteoarthritis (Tönnis grade 2)
- Unable to speak/understand English
- Currently imprisoned
- Unwilling/unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health System
Columbia, Missouri, 65212
About this study
Official title: Use of Regional Anesthesia in Hip Arthroscopy
The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.
Read the detailed description
Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).
- Conditions
- Femoroacetabular Impingement
- Being tested
- regional anesthesia bupivacaine, regional anesthesia placebo
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesia bupivacaineDrug
Also called Exparel, Sensorcaine, Marcaine
a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
regional anesthesia placeboDrug
Also called Sodium Chloride Injection
subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia bupivacaine | Active comparator | regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy Receives: Drug: regional anesthesia bupivacaine |
| regional anesthesia placebo | Placebo comparator | subcutaneous injection procedure placebo (0.9% sodium chloride in water) Receives: Drug: regional anesthesia placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject log to record number of pain pills taken by subject for 7 days
A log that is used by the subject to record how many oral pain medications they take for 7 days.
Measured: 7 days
Secondary outcomes (10)
Record of Pain Medication given in PACU
Record narcotic requirements in PACU
Measured: immediately post-op (while in PACU, on average 1-4 hours total)
Harris Hip score
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Measured: 6 weeks
Visual analog pain scale
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Measured: 6 weeks
iHOT-12 (international hip outcome tool)
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Measured: 6 weeks
HOOS (hip disability and osteoarthritis outcome score)
Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.
Measured: 6 weeks
Duration of time in PACU
Measured: immediately post-op, on average between 1-4 hours
Reported Falls Post-op
Measured: Time inpatient, on average 12-48 hours
Unplanned admissions and/or readmissions
number of unplanned admissions/readmission
Measured: 6 weeks
Days until starting rehabilitation
Measured: immediately post-op, on average 24 hours - 2 weeks
Patient satisfaction
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: determined not to be feasible at our site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Aggarwal, University of Missouri-Columbia
- Investigators
- Ajay Aggarwal, MD, Principal investigator, University of Missouri Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674113
- Sponsor's protocol ID
- 1211908
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Regional Anesthesia in Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT02674113
- Acronym / sponsor ID
- 1211908
- Conditions
- Femoroacetabular Impingement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: determined not to be feasible at our site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
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 research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.
Detailed description
Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia bupivacaine | Active comparator | Drug: regional anesthesia bupivacaineregional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy |
| regional anesthesia placebo | Placebo comparator | Drug: regional anesthesia placebosubcutaneous injection procedure placebo (0.9% sodium chloride in water) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
- Age 18-45 years old
- Not pregnant
- No history of neuropathic pain
- No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
Key exclusion criteria (8 listed)
- Allergy to regional anesthetic
- Age <18 or >45 years
- Pregnant females
- History of neuropathic pain
- Radiographic signs of osteoarthritis (Tönnis grade 2)
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 |
|---|---|---|
| regional anesthesia bupivacaineAlso: Exparel, Sensorcaine, Marcainea single shot fascia iliaca block using bupivacaine prior to hip arthroscopy | Drug | regional anesthesia bupivacaine |
| regional anesthesia placeboAlso: Sodium Chloride Injectionsubcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) | Drug | regional anesthesia placebo |
Primary outcome
Subject log to record number of pain pills taken by subject for 7 days
Time frame: 7 days
A log that is used by the subject to record how many oral pain medications they take for 7 days.
10 secondary outcomes
Record of Pain Medication given in PACU
Time frame: immediately post-op (while in PACU, on average 1-4 hours total)
Harris Hip score
Time frame: 6 weeks
Visual analog pain scale
Time frame: 6 weeks
iHOT-12 (international hip outcome tool)
Time frame: 6 weeks
HOOS (hip disability and osteoarthritis outcome score)
Time frame: 6 weeks
Duration of time in PACU
Time frame: immediately post-op, on average between 1-4 hours
Reported Falls Post-op
Time frame: Time inpatient, on average 12-48 hours
Unplanned admissions and/or readmissions
Time frame: 6 weeks
Days until starting rehabilitation
Time frame: immediately post-op, on average 24 hours - 2 weeks
Patient satisfaction
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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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.
Ajay Aggarwal, MD principal investigator
University of Missouri Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional anesthesia bupivacaine in people with Femoroacetabular Impingement, run by University of Missouri-Columbia 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Feb 2017. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Subject log to record number of pain pills taken by subject for 7 days (time frame: 7 days). 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 10 Feb 2017.