Clinical trial NCT02851888: Use of Regional Anesthesia in Hip Arthroscopy
Official title: Use of Regional Anesthesia in Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Injuries
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Union Memorial Hospital
First posted: 2016-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Medication Requirement in PACU
timeFrame: 24 hours post-operatively
Secondary outcomes:
measure: Falls
timeFrame: 6 weeks
measure: Readmissions
timeFrame: 6 weeks
measure: Neuropathic Pain
timeFrame: 2 weeks and 6 weeks
measure: Time to Physical Therapy
timeFrame: 6 weeks
measure: Duration of PACU stay (mins)
timeFrame: 24 hours post-operatively
measure: Visual Analogue Pain Scores (VAS)
timeFrame: 24 hours post-operatively
measure: Long Term Pain Control (daily VAS record)
timeFrame: 6 weeks
measure: 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)
timeFrame: 6 weeks
measure: Modified Harris hip score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Blake Bodendorfer, MD
role: PRINCIPAL_INVESTIGATOR
References: