Hip Arthroscopy Pain Control Randomized Control Trial (RCT)

Summary

Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgical hip dislocation was performed to treat patients with this condition, however with recent advances in arthroscopy, patients more commonly now undergo arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide peri-operative analgesia included intraarticular or portal analgesic injections. More recently, regional anesthesia techniques are being employed to provide more reliable and longer lasting post-operative pain control.3, 4 Currently, there are several local anesthetics available for regional anesthesia. However, they only provide an average of 12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a local anesthetic that has been used for many years by multiple routes to control post-operative pain. A new formulation of the medication prolongs the release of the active ingredient after a single injection and has been shown to result in up to 72 hours of post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the literature comparing a historical control local anesthetic to this new formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to provide post operative pain control following hip arthroscopy.

Conditions

• Hip Pain Chronic
• Anesthesia
• Bupivacaine

Interventions

PROCEDURE

Fascial iliac regional soft tissue infiltration blockade

Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy)

BEHAVIORAL

Pain Score Survey

Utilizing: Defense and Veterans Pain Rating Scale (DVPRS)

BEHAVIORAL

Pill Count

Patient reported as needed (prn) pain medication usage

DRUG

Bupivacaine

DRUG

Liposomal Bupivacaine

Sponsors & Collaborators

• Walter Reed National Military Medical Center

  lead FED

Principal Investigators

• Michael Kent, MD · Walter Reed National Military Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-01

Primary Completion

2017-03-01

Completion

2017-03-01

Countries

• United States

Study Locations