Hip InjuriesPhase 4NCT02851888
Use of Regional Anesthesia in Hip Arthroscopy
A Phase 4 study testing Ropivacaine and General Anesthesia in people with Hip Injuries, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) 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 50 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Ropivacaine and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2018
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for arthroscopic labral repair with or without osteoplasty of the hip.
- 18 to 50 years old
- American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.
Who cannot join
- Current or planned pregnancy
- History of neuropathic pain, chronic pain syndrome, or preoperative use of narcotic or neuropathic pain medicine
- Radiographic signs of osteoarthritis (> Tonis grade 1)
- Inability to attend follow up visits
- Documented allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
John Mawn, BS, 262-488-3210, jm2564@georgetown.edu
About this study
The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement
Read the detailed description
Patients undergoing hip arthroscopy for hip impingement at the investigator's institution often have regional anesthesia (a nerve block) prior to the procedure to help prevent and/or reduce pain following the procedure. The investigators are interested in determining benefits as well as potential adverse effects of utilizing regional anesthesia in patients undergoing hip arthroscopy for impingement. To do so, they plan to enroll patients aged 18-50 undergoing hip arthroscopy, and randomize them to one of two groups with one group receiving regional anesthesia pre-operatively and the second control group, that does not. The surgical procedure and the post-operative management will be the same for both groups.
Regional anesthesia prior to orthopaedic procedures has been widely adopted in many fields of orthopaedics. While it is generally considered safe and an excellent adjuvant for pain control, there have been few studies exploring outcomes beyond pain control. In many centers, the use of regional anesthesia in hip arthroscopy is reserved for post-operative management of pain. There are multiple studies indicating that patients receiving regional anesthesia (a fascia iliaca or femoral nerve block) had significantly greater improvements in pain score and even an excellent alternative to routine narcotic medication in patients undergoing hip arthroscopy. Other orthopaedic procedures, such as knee arthroscopy, utilize similar techniques to achieve post-operative pain control through a femoral-sciatic nerve block.
There have also been studies looking at the utilization of regional anesthesia via lumbar plexus blocks with hip arthroscopy. One study found that patients undergoing hip arthroscopy with higher levels of preoperative psychological distress frequently utilized a lumbar plexus block to achieve adequate pain control. Other studies found that lumbar plexus blocks significantly improved pain while in the PACU. While serious complications of lumbar plexus block were rare, minor complications such as falls, persistent paresthesias, and unexpected admissions do occur. At our institution, we do not utilize lumbar plexus blocks for regional anesthesia in patients undergoing hip arthroscopy. Rather, our standard of care is to have an anesthesiologist perform a single shot fascia iliaca block using ropivicaine while the patient is in the pre-operative holding bay.
To the investigative team's knowledge, there are no studies comparing the difference in pain control, as well as the differences in narcotic requirements in PACU, duration of stay in PACU, reported falls, unplanned admissions and/or readmissions, Harris hip score and nerve pain/paresthesias/numbness in patients who have undergone hip arthroscopy with and without regional anesthesia. A better understanding of pain and functional outcomes following hip arthroscopy with and without regional anesthesia can help providers better assess circumstances when regional anesthesia can be beneficial or detrimental to a patient's post-operative course.
- Conditions
- Hip Injuries
- Being tested
- Ropivacaine, Normal Saline Sham Injection, General Anesthesia
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Iliac Fascia Block
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
Normal Saline Sham InjectionOther
Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
General AnesthesiaProcedure or surgery
Patients were induced and maintained in a fashion consistent with standard practices.
| Study group | Role | What they receive |
|---|---|---|
| Iliac Fascia Block (Ropivacaine) | Experimental | These patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia. Receives: Drug: Ropivacaine; Procedure: General Anesthesia |
| Control (Normal Saline Sham Injection) | Sham comparator | These patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia. Receives: Other: Normal Saline Sham Injection; Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Medication Requirement in PACU
Measured in morphine equivalents
Measured: 24 hours post-operatively
Secondary outcomes (9)
Falls
patient reported
Measured: 6 weeks
Readmissions
patient reported and through chart review
Measured: 6 weeks
Neuropathic Pain
Self Reported- Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaires will be completed at both 2 and 6 week follow-up
Measured: 2 weeks and 6 weeks
Time to Physical Therapy
patient reported
Measured: 6 weeks
Duration of PACU stay (mins)
time from PACU admission to discharge
Measured: 24 hours post-operatively
Visual Analogue Pain Scores (VAS)
patient reported
Measured: 24 hours post-operatively
Long Term Pain Control (daily VAS record)
Patients will complete a daily VAS questionnaire at home
Measured: 6 weeks
Long Term Medication Requirements (daily log of medication usage in tablets of 5 mg oxycodone, morphine extended relief 15 mg, and/or indomethacin 75 mg)
Patients will complete a daily medication log at home
Measured: 6 weeks
Modified Harris hip score
Questionnaire administered at 6 week follow up to evaluate functional outcomes
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 posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by Georgetown 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Union Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Blake Bodendorfer, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851888
- Sponsor's protocol ID
- 2016-0095
- Status last verified
- Nov 2017
- First submitted
- 26 Jul 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. 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
- NCT02851888
- Acronym / sponsor ID
- 2016-0095
- Conditions
- Hip Injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Union Memorial Hospital
- Study start
- Jul 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 2 Aug 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 do, or do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement
Detailed description
Patients undergoing hip arthroscopy for hip impingement at the investigator's institution often have regional anesthesia (a nerve block) prior to the procedure to help prevent and/or reduce pain following the procedure. The investigators are interested in determining benefits as well as potential adverse effects of utilizing regional anesthesia in patients undergoing hip arthroscopy for impingement. To do so, they plan to enroll patients aged 18-50 undergoing hip arthroscopy, and randomize them to one of two groups with one group receiving regional anesthesia pre-operatively and the second control group, that does not. The surgical procedure and the post-operative management will be the same for both groups.
Regional anesthesia prior to orthopaedic procedures has been widely adopted in many fields of orthopaedics. While it is generally considered safe and an excellent adjuvant for pain control, there have been few studies exploring outcomes beyond pain control. In many centers, the use of regional anesthesia in hip arthroscopy is reserved for post-operative management of pain. There are multiple studies indicating that patients receiving regional anesthesia (a fascia iliaca or femoral nerve block) had significantly greater improvements in pain score and even an excellent alternative to routine narcotic medication in patients undergoing hip arthroscopy. Other orthopaedic procedures, such as knee arthroscopy, utilize similar techniques to achieve post-operative pain control through a femoral-sciatic nerve block.
There have also been studies looking at the utilization of regional anesthesia via lumbar plexus blocks with hip arthroscopy. One study found that patients undergoing hip arthroscopy with higher levels of preoperative psychological distress frequently utilized a lumbar plexus block to achieve adequate pain control. Other studies found that lumbar plexus blocks significantly improved pain while in the PACU. While serious complications of lumbar plexus block were rare, minor complications such as falls, persistent paresthesias, and unexpected admissions do occur. At our institution, we do not utilize lumbar plexus blocks for regional anesthesia in patients undergoing hip arthroscopy. Rather, our standard of care is to have an anesthesiologist perform a single shot fascia iliaca block using ropivicaine while the patient is in the pre-operative holding bay.
To the investigative team's knowledge, there are no studies comparing the difference in pain control, as well as the differences in narcotic requirements in PACU, duration of stay in PACU, reported falls, unplanned admissions and/or readmissions, Harris hip score and nerve pain/paresthesias/numbness in patients who have undergone hip arthroscopy with and without regional anesthesia. A better understanding of pain and functional outcomes following hip arthroscopy with and without regional anesthesia can help providers better assess circumstances when regional anesthesia can be beneficial or detrimental to a patient's post-operative course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iliac Fascia Block (Ropivacaine) | Experimental | Drug: Ropivacaine, Procedure: General AnesthesiaThese patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia. |
| Control (Normal Saline Sham Injection) | Sham comparator | Other: Normal Saline Sham Injection, Procedure: General AnesthesiaThese patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Scheduled for arthroscopic labral repair with or without osteoplasty of the hip.
- 18 to 50 years old
- American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.
Key exclusion criteria (5 listed)
- Current or planned pregnancy
- History of neuropathic pain, chronic pain syndrome, or preoperative use of narcotic or neuropathic pain medicine
- Radiographic signs of osteoarthritis (> Tonis grade 1)
- Inability to attend follow up visits
- Documented allergy to local anesthetic
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 |
|---|---|---|
| RopivacaineAlso: Iliac Fascia BlockIliac fascia block was performed in the experimental group with a single shot of Ropavicaine. | Drug | Iliac Fascia Block (Ropivacaine) |
| Normal Saline Sham InjectionSham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique. | Other | Control (Normal Saline Sham Injection) |
| General AnesthesiaPatients were induced and maintained in a fashion consistent with standard practices. | Procedure or surgery | Control (Normal Saline Sham Injection), Iliac Fascia Block (Ropivacaine) |
Primary outcome
Pain Medication Requirement in PACU
Time frame: 24 hours post-operatively
Measured in morphine equivalents
9 secondary outcomes
Falls
Time frame: 6 weeks
Readmissions
Time frame: 6 weeks
Neuropathic Pain
Time frame: 2 weeks and 6 weeks
Time to Physical Therapy
Time frame: 6 weeks
Duration of PACU stay (mins)
Time frame: 24 hours post-operatively
Visual Analogue Pain Scores (VAS)
Time frame: 24 hours post-operatively
Long Term Pain Control (daily VAS record)
Time frame: 6 weeks
Long Term Medication Requirements (daily log of medication usage in tablets of 5 mg oxycodone, morphine extended relief 15 mg, and/or indomethacin 75 mg)
Time frame: 6 weeks
Modified Harris hip score
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- 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.
Blake Bodendorfer, MD principal investigator
Georgetown University
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 Ropivacaine and General Anesthesia in people with Hip Injuries, run by Georgetown 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 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John G Mawn, BS (2624883210, jm2564@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Medication Requirement in PACU (time frame: 24 hours post-operatively). 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 Feb 2018.