Use of Regional Anesthesia in Hip Arthroscopy

Hip Injuries Clinical Trial

Official title:

Use of Regional Anesthesia in Hip Arthroscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02851888
• Other study ID #: 2016-0095
• Status: Recruiting
• Phase: Phase 4
• First received: July 26, 2016
• Last updated: February 14, 2018
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Georgetown University
• Contact: John G Mawn, BS
• Phone: 2624883210
• Email: jm2564[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries

Intervention

Drug:
• Ropivacaine
Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.

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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Union Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

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