Hip Arthroscopy Pain Control Randomized Control Trial (RCT)
Condition: Hip Pain Chronic; Anesthesia; Bupivacaine
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study is a double-blinded prospective randomized control trial. Patients will be
      randomized in a 1:1 ratio to either the liposomal bupivacaine group versus bupivacaine alone.
      Randomization assignment will be determined using a computer program based on random number
      generation, with an equal number of treatments in blocks of 2, 4, and 6 patients. The order
      of the blocks will be randomized as well. Treatment assignments will be concealed in
      sequentially numbered opaque sealed envelopes (SNOSE). The anesthesia provider administering
      the medication will not be an investigator of this study and will be allowed to know what
      medication that is administered to ensure safety with regards to any potential medication
      interactions the study medication may have with any other medication or anesthesia provided
      during the operation. This study will be double blinded by having the associate investigator
      (anesthesia resident/fellow) that will be conducting the post-operative pain score, Defense
      and Veterans Pain Rating Scale (DVPRS) evaluations, un-aware of which medication each patient
      received during the fascial iliac regional soft tissue infiltration blockade. The anesthesia
      resident/fellow will remain blinded to which medication the patient received by not having
      access to the patients electronic medical record, did not participate in the procedure, and
      will not have access to the database created by the orthopaedics residents where this
      information will be entered. The treating surgeons will also be blinded to which medication
      was administered by not being present during the randomization process and will only be made
      aware of which medication the patient received after the final two-week postoperative pain
      assessment and oral pain medication pill count, after which patient study participation will
      be concluded. The success of blinding will be evaluated by asking the patient, anesthesia
      resident/fellow and treating surgeon to guess their treatment assignment the day of surgery,
      during the pain score collection process and at the final two-week routine follow up
      appointment.
    

Intervention name(s): Fascial iliac regional soft tissue infiltration blockade; Pain Score Survey; Pill Count; Bupivacaine; Liposomal Bupivacaine
Intervention type(s): Procedure; Behavioral; Behavioral; Drug; Drug
Intervention description(s): Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy); Utilizing: Defense and Veterans Pain Rating Scale (DVPRS); Patient reported as needed (prn) pain medication usage
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention