Regional Anesthesia in Hip Arthroscopy

Overview

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.

Full Title of Study: “Use of Regional Anesthesia in Hip Arthroscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2017

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).

Interventions

  • Drug: regional anesthesia bupivacaine
    • a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
  • Drug: regional anesthesia placebo
    • subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)

Arms, Groups and Cohorts

  • Active Comparator: regional anesthesia bupivacaine
    • regional anesthesia (a single shot fascia iliaca block using bupivacaine) prior to hip arthroscopy
  • Placebo Comparator: regional anesthesia placebo
    • subcutaneous injection procedure placebo (0.9% sodium chloride in water)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Missouri-Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ajay Aggarwal, Assistant Professor of Orthopedic Surgery – University of Missouri-Columbia
  • Overall Official(s)
    • Ajay Aggarwal, MD, Principal Investigator, University of Missouri Health System

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