Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2016-07-31
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Regional Anesthesia in Hip Arthroscopy
NCT02674113
The Analgesic Efficacy of the Ultrasound-Guided Femoral Articular Branch Block for Ambulatory Hip Arthroscopy
NCT03449680
Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy
NCT04538105
FAB Block vs. Placebo for Hip Arthroplasty Patients
NCT04301687
Fascia Iliaca Blocks and Pre-operative Opioid Requirements in Hip Fracture Patients
NCT02804542
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Iliac Fascia Block (Ropivacaine)
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.
Ropivacaine
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
General Anesthesia
Patients were induced and maintained in a fashion consistent with standard practices.
Control (Normal Saline Sham Injection)
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.
Normal Saline Sham Injection
Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
General Anesthesia
Patients were induced and maintained in a fashion consistent with standard practices.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ropivacaine
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
Normal Saline Sham Injection
Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
General Anesthesia
Patients were induced and maintained in a fashion consistent with standard practices.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 to 50 years old
* American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Union Memorial Hospital
OTHER
Georgetown University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Blake Bodendorfer, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-0095
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.