LIA in Hip Arthroscopy Patients

NCT ID: NCT03070054

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

non-LIA group prior to surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment

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

Group Type: EXPERIMENTAL

20ml 0.25% bupivacaine-epinephrine

Intervention Type: DRUG

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

Interventions

20ml 0.25% bupivacaine-epinephrine

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

Intervention Type: DRUG

Other Intervention Names

Marcaine, Sensorcaine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Aoki, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

90371

Identifier Type: -

Identifier Source: org_study_id