Regional Anesthesia in Hip Arthroscopy

Use of Regional Anesthesia in Hip Arthroscopy

The purpose of this research is to determine differences in outcomes in patients who receive regional anesthesia (a fascia iliaca block) versus placebo prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement.

Study Overview

• Status: Withdrawn
• Conditions: Femoroacetabular Impingement
• Intervention / Treatment: Drug: regional anesthesia bupivacaine; Drug: regional anesthesia placebo

Detailed Description

Methods: After informed consent is obtained at a routine/pre-surgical clinic visit, all patients who meet eligibility criteria will undergo randomization into one of two groups. These groups are 1) to receive regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy, or 2) undergo a subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water) instead of bupivacaine. Intra-operatively, both groups will receive general anesthesia and local anesthesia (lidocaine and bupivacaine in the peripheral compartment).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient undergoing primary hip arthroscopy with labral repair and osteoplasty for hip impingement
• Age 18-45 years old
• Not pregnant
• No history of neuropathic pain
• No radiographic signs of osteoarthritis of the operative hip (Tönnisgrade 1)
• Willing and able to comply with post-operative hip arthroscopy protocol
• No documented allergy to anesthetic agents
• Able to attend follow up appointments

Exclusion Criteria:

• Allergy to regional anesthetic
• Age <18 or >45 years
• Pregnant females
• History of neuropathic pain
• Radiographic signs of osteoarthritis (Tönnis grade 2)
• Unable to speak/understand English
• Currently imprisoned
• Unwilling/unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: regional anesthesia bupivacaine; regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy	Drug: regional anesthesia bupivacaine; a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy; Other Names: Marcaine; Exparel; Sensorcaine
Placebo Comparator: regional anesthesia placebo; subcutaneous injection procedure placebo (0.9% sodium chloride in water)	Drug: regional anesthesia placebo; subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water); Other Names: Sodium Chloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject log to record number of pain pills taken by subject for 7 days	A log that is used by the subject to record how many oral pain medications they take for 7 days.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction		6 weeks
Record of Pain Medication given in PACU	Record narcotic requirements in PACU	immediately post-op (while in PACU, on average 1-4 hours total)
Harris Hip score	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Visual analog pain scale	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
iHOT-12 (international hip outcome tool)	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
HOOS (hip disability and osteoarthritis outcome score)	Patient reported outcome. These will be completed at the pre-operative and all post-operative clinic visits.	6 weeks
Duration of time in PACU		immediately post-op, on average between 1-4 hours
Reported Falls Post-op		Time inpatient, on average 12-48 hours
Unplanned admissions and/or readmissions	number of unplanned admissions/readmission	6 weeks
Days until starting rehabilitation		immediately post-op, on average 24 hours - 2 weeks

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Ajay Aggarwal, MD, University of Missouri Health System

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: November 7, 2015
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: 1211908