LIA in Hip Arthroscopy Patients

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ClinicalTrials.gov Identifier: NCT03070054

Recruitment Status : Enrolling by invitation

First Posted : March 3, 2017

Last Update Posted : June 6, 2018

Sponsor:

Information provided by (Responsible Party):

Stephen Aoki, University of Utah

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
Pain	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 (Clinical Trial)
Estimated 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 :	June 2016
Estimated Primary Completion Date :	June 2021
Estimated Study Completion Date :	June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

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 Name: Marcaine, Sensorcaine

Outcome Measures

Primary Outcome Measures :

PACU pain scores [ Time Frame: 1-day ]
Patient-reported pain in the postoperative anesthesia care unit (PACU).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070054

Locations


United States, Utah
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

More Information


Responsible Party:	Stephen Aoki, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier:	NCT03070054 History of Changes
Other Study ID Numbers:	90371
First Posted:	March 3, 2017 Key Record Dates
Last Update Posted:	June 6, 2018
Last Verified:	June 2018
Individual Participant Data (IPD) Sharing Statement:
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:


Bupivacaine Epinephrine Racepinephrine Epinephryl borate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-Agonists Adrenergic Agonists	Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

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