Use of Regional Anesthesia in Hip Arthroscopy

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

Study Overview

• Status: Unknown
• Conditions: Hip Injuries
• Intervention / Treatment: Drug: Ropivacaine; Procedure: General Anesthesia; Other: Normal Saline Sham Injection

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University Medical Center
      • Contact: John Mawn, BS; Phone Number: 262-488-3210; Email: jm2564@georgetown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Procedure: General Anesthesia; Patients were induced and maintained in a fashion consistent with standard practices.; Other: Normal Saline Sham Injection; Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Medication Requirement in PACU	Measured in morphine equivalents	24 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	patient reported	6 weeks
Readmissions	patient reported and through chart review	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	2 weeks and 6 weeks
Time to Physical Therapy	patient reported	6 weeks
Duration of PACU stay (mins)	time from PACU admission to discharge	24 hours post-operatively
Visual Analogue Pain Scores (VAS)	patient reported	24 hours post-operatively
Long Term Pain Control (daily VAS record)	Patients will complete a daily VAS questionnaire at home	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	6 weeks
Modified Harris hip score	Questionnaire administered at 6 week follow up to evaluate functional outcomes	6 weeks

Collaborators and Investigators

• Sponsor: Georgetown University
• Collaborators: Union Memorial Hospital
• Investigators: Principal Investigator: Blake Bodendorfer, MD, Georgetown University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2016-0095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO