Use of Regional Anesthesia in Hip Arthroscopy

Sponsor
Georgetown University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02851888
Collaborator
Union Memorial Hospital (Other)
70
1
2
25
2.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine
  • Other: Normal Saline Sham Injection
  • Procedure: General Anesthesia
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Use of Regional Anesthesia in Hip Arthroscopy
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Ropivacaine
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
Other Names:
  • Iliac Fascia Block
  • Procedure: General Anesthesia
    Patients were induced and maintained in a fashion consistent with standard practices.

    Sham Comparator: 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.

    Other: Normal Saline Sham Injection
    Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.

    Procedure: General Anesthesia
    Patients were induced and maintained in a fashion consistent with standard practices.

    Outcome Measures

    Primary Outcome Measures

    1. Pain Medication Requirement in PACU [24 hours post-operatively]

      Measured in morphine equivalents

    Secondary Outcome Measures

    1. Falls [6 weeks]

      patient reported

    2. Readmissions [6 weeks]

      patient reported and through chart review

    3. Neuropathic Pain [2 weeks and 6 weeks]

      Self Reported- Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaires will be completed at both 2 and 6 week follow-up

    4. Time to Physical Therapy [6 weeks]

      patient reported

    5. Duration of PACU stay (mins) [24 hours post-operatively]

      time from PACU admission to discharge

    6. Visual Analogue Pain Scores (VAS) [24 hours post-operatively]

      patient reported

    7. Long Term Pain Control (daily VAS record) [6 weeks]

      Patients will complete a daily VAS questionnaire at home

    8. 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) [6 weeks]

      Patients will complete a daily medication log at home

    9. Modified Harris hip score [6 weeks]

      Questionnaire administered at 6 week follow up to evaluate functional outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Georgetown University Medical Center Washington District of Columbia United States 20007

    Sponsors and Collaborators

    • Georgetown University
    • Union Memorial Hospital

    Investigators

    • Principal Investigator: Blake Bodendorfer, MD, Georgetown University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Georgetown University
    ClinicalTrials.gov Identifier:
    NCT02851888
    Other Study ID Numbers:
    • 2016-0095
    First Posted:
    Aug 2, 2016
    Last Update Posted:
    Feb 19, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 19, 2018