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Use of Regional Anesthesia in Hip Arthroscopy

Primary Purpose

Hip Injuries

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Normal Saline Sham Injection
General Anesthesia
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgetown University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Iliac Fascia Block (Ropivacaine)

Control (Normal Saline Sham Injection)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Medication Requirement in PACU
Measured in morphine equivalents

Secondary Outcome Measures

Falls
patient reported
Readmissions
patient reported and through chart review
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
Time to Physical Therapy
patient reported
Duration of PACU stay (mins)
time from PACU admission to discharge
Visual Analogue Pain Scores (VAS)
patient reported
Long Term Pain Control (daily VAS record)
Patients will complete a daily VAS questionnaire at home
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
Modified Harris hip score
Questionnaire administered at 6 week follow up to evaluate functional outcomes

Full Information

First Posted
July 26, 2016
Last Updated
February 14, 2018
Sponsor
Georgetown University
Collaborators
Union Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02851888
Brief Title
Use of Regional Anesthesia in Hip Arthroscopy
Official Title
Use of Regional Anesthesia in Hip Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Union Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iliac Fascia Block (Ropivacaine)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Normal Saline Sham Injection)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Iliac Fascia Block
Intervention Description
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
Intervention Type
Other
Intervention Name(s)
Normal Saline Sham Injection
Intervention Description
Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Intervention Description
Patients were induced and maintained in a fashion consistent with standard practices.
Primary Outcome Measure Information:
Title
Pain Medication Requirement in PACU
Description
Measured in morphine equivalents
Time Frame
24 hours post-operatively
Secondary Outcome Measure Information:
Title
Falls
Description
patient reported
Time Frame
6 weeks
Title
Readmissions
Description
patient reported and through chart review
Time Frame
6 weeks
Title
Neuropathic Pain
Description
Self Reported- Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaires will be completed at both 2 and 6 week follow-up
Time Frame
2 weeks and 6 weeks
Title
Time to Physical Therapy
Description
patient reported
Time Frame
6 weeks
Title
Duration of PACU stay (mins)
Description
time from PACU admission to discharge
Time Frame
24 hours post-operatively
Title
Visual Analogue Pain Scores (VAS)
Description
patient reported
Time Frame
24 hours post-operatively
Title
Long Term Pain Control (daily VAS record)
Description
Patients will complete a daily VAS questionnaire at home
Time Frame
6 weeks
Title
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)
Description
Patients will complete a daily medication log at home
Time Frame
6 weeks
Title
Modified Harris hip score
Description
Questionnaire administered at 6 week follow up to evaluate functional outcomes
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John G Mawn, BS
Phone
2624883210
Email
jm2564@georgetown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica B Hawken, BA
Phone
7039949605
Email
jesshawken13@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blake Bodendorfer, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Mawn, BS
Phone
262-488-3210
Email
jm2564@georgetown.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Regional Anesthesia in Hip Arthroscopy

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