Hip DysplasiaPhase 4NCT02365961
Hip Scope Fascia-iliaca (FI) Block Study
A Phase 4 study testing ropivicaine, clonidine and Epinephrine in people with Hip Dysplasia and Femoroacetabular Impingement, run by The Hawkins Foundation at 1 site in United States.
Trial summary
Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Dysplasia, Femoroacetabular Impingement, Acetabular Labrum Tear
- What is being tested?
- ropivicaine, clonidine and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jun 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for outpatient hip arthroscopy
- American Society of Anesthesiologists (ASA) 1-3
Who cannot join
- Prior surgery on ipsilateral hip
- ASA 4-6
- Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
- Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
- Allergy to amide local anesthetics
- Contraindication to regional anesthesia
- BMI > 40
- Females who are pregnant or plan to get pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block
Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.
- Being tested
- ropivicaine, clonidine, Epinephrine, Noropin
- Keywords
- Hip Arthroscopy
- Medical subject headings
- Hip Dislocation, Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivicaineDrug
clonidineDrug
EpinephrineDrug
NoropinDrug
| Study group | Role | What they receive |
|---|---|---|
| FI Block | Experimental | Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) Receives: Drug: ropivicaine; Drug: clonidine; Drug: Epinephrine |
| Local Injection | Active comparator | Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin Receives: Drug: Noropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.
Measured: 3 Months
Secondary outcomes (1)
Opioid Consumption
Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Kim, MD, Principal investigator, Greenville Anesthesiology - Greenville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365961
- Sponsor's protocol ID
- Pro00038232
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2015
- Last updated
- 14 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.
PubMed 31999469
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block
- ClinicalTrials.gov ID
- NCT02365961
- Acronym / sponsor ID
- Pro00038232
- Keywords
- Hip Arthroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FI Block | Experimental | Drug: ropivicaine, Drug: clonidine, Drug: EpinephrineFascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine [per 60 mL] and epinephrine 1:400,000) |
| Local Injection | Active comparator | Drug: NoropinLocal anesthetic in the hip joint consisting of 30cc of 0.5% Noropin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for outpatient hip arthroscopy
- American Society of Anesthesiologists (ASA) 1-3
Key exclusion criteria (8 listed)
- Prior surgery on ipsilateral hip
- ASA 4-6
- Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
- Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
- Allergy to amide local anesthetics
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 |
|---|---|---|
| ropivicaine | Drug | FI Block |
| clonidine | Drug | FI Block |
| Epinephrine | Drug | FI Block |
| Noropin | Drug | Local Injection |
Primary outcome
Visual Analog Scale
Time frame: 3 Months
Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.
1 secondary outcome
Opioid Consumption
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31999469Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.
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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.
Eugene Kim, MD principal investigator
Greenville Anesthesiology - Greenville Health System
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 ropivicaine, clonidine and Epinephrine in people with Hip Dysplasia and Femoroacetabular Impingement, run by The Hawkins Foundation 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 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: finished, as of the sponsor's last update on 14 Mar 2019. 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 14 Mar 2019). 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 Analog Scale (time frame: 3 Months). 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 NCT02365961, which also lists 1 linked publication.
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 14 Mar 2019.