LIA in Hip Arthroscopy Patients

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT03070054
Collaborator
(none)
74
1
2
45
1.6

Study Details

Study Description

Brief Summary

The investigator's are conducting a randomized, blinded study to determine if the extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine can improve the postoperative pain management of hip arthroscopy patients. Participants will be randomly assigned to the LIA group or non-LIA group prior to surgery. Participants, anesthesiologists and PACU nurses will be blinded to group assignment, however the surgeon administering the LIA will be unblinded.

Condition or Disease Intervention/Treatment Phase
  • Drug: 20ml 0.25% bupivacaine-epinephrine
Early Phase 1

Detailed Description

Hip arthroscopy is a growing field in orthopedic medicine that has gained momentum in recent years as a treatment for an array of hip pathologies including labral tears, chondral injuries, loose bodies, hip instability, femoroacetabular impingement, extraarticular lesions, synovial abnormalities, ruptured ligamentum teres, osteonecrosis, and mild-to-moderate osteoarthritis. With this increased rate of hip arthroscopy has come an interest in adequate postoperative pain management.

There are a number of strategies to improve post-operative orthopedic pain management. One common technique is the femoral block, during which a patient receives an ultrasound-guided injection of local analgesia administered in close proximity to the nerve. In the hip arthroscopy setting, postoperative femoral nerve blocks have been shown to significantly decrease pain, reduce opioid related symptoms like nausea, and have higher pain satisfaction scores than patients using only morphine. However, this option can be costly as it is a separate procedure billed by the anesthesiologist. Regional nerve blocks also carry the risk of residual parasthesia and permanent nerve damage, however rare.

One way to circumvent these limitations is through local infiltration analgesia (LIA), a technique that has been described for post-operative pain management in orthopedic modalities like total knee arthroscopy (TKA) and total hip arthroscopy (THA). Injection of analgesic directly to the surgical site can easily be incorporated as a brief step in the surgical procedure at a minimal cost to the patient. In THA and TKA, LIA has resulted in promising decreases in pain and opioid consumption. However, interpretation of these results in the context of hip arthroscopy has been confounded by the fundamental differences between THA/TKA and hip arthroscopy, the array of different strategies used in LIA (eg. continuous infiltration via a catheter vs. a single shot), and a lack of placebo or control group, and the specific location of injection.

In the setting of hip arthroscopy, a previous group tested intra-portal injections with mixed results. LIA targeting the highly innervated hip capsule, which is cut to access the joint during arthroscopy, may be more efficacious at limiting postoperative pain. LIA injection into the hip capsule can occur under direct visualization after capsular repair. To our knowledge, no studies have assessed the outcomes of this extracapsular LIA technique in the hip arthroscopy setting.

Documented risks involved with LIA are limited to the continuous infiltration via catheter. This approach has the risk of infection at the catheter site as well as cartilage damage. Our proposed technique avoids use of catheters and associated infection. The proposed single dose of 0.25% 20mL bupivacaine epinephrine a fraction of the dosages used in previous LIA studies to avoid chondral damage.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants, anesthesiologists and PACU nurses will be blinded to group assignment, however the surgeon administering the LIA will be unblinded.
Primary Purpose:
Treatment
Official Title:
LIA in Hip Arthroscopy Patients: An Extra-Capsular Approach
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

non-LIA group prior to surgery

Experimental: Treatment

Extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine

Drug: 20ml 0.25% bupivacaine-epinephrine
Extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine
Other Names:
  • Marcaine, Sensorcaine
  • Outcome Measures

    Primary Outcome Measures

    1. PACU pain scores [1-day]

      Patient-reported pain in the postoperative anesthesia care unit (PACU).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult (>18 years) patients who have elected for hip arthroscopy surgery.
    Exclusion Criteria:
    • Patients who are undergoing bilateral hip arthroscopy in a single surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Orthopaedic Center Salt Lake City Utah United States 84108

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Stephen Aoki, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephen Aoki, Principle Investigator, University of Utah
    ClinicalTrials.gov Identifier:
    NCT03070054
    Other Study ID Numbers:
    • 90371
    First Posted:
    Mar 3, 2017
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2020