Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare two medications currently injected intra-operatively
      to help decrease pain after surgery in patients undergoing a primary total hip replacement
      (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus
      bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to
      see if one medication works better than the other in managing post-operative pain after THR.
      The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate
      better pain management in THR patients post-operatively. Both medications are FDA-approved
      for post-operative analgesia.
    

Detailed description: 
      All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving
      Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB
      group) and the other receiving bupivacaine with epinephrine (Control group), will be compared
      using post-operative pain scores, hospital length of stay, time to ambulation, falls,
      narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all
      outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was
      performed to calculate the total number of patients that needed to be enrolled to achieve a
      minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a
      previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post
      THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least
      26 patients were necessary in each group for an adequately powered assessment. The diagnosis
      for osteoarthritis was determined by patient history, physical examination, and imaging
      findings. Each patient received a thorough explanation of the protocol, and willing patients
      signed an informed consent form. All patients underwent a personal preoperative education
      program regarding pre, intra-, and post-procedural information including physical therapy,
      expectations, discharge goals, home therapy, and pain management. After written consent was
      collected, the form was sent to the hospital pharmacy for randomization. Envelopes were
      randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the
      envelopes to the nurse in the operating room in numerical order. The pharmacy documented the
      required information, selected medication, and drug accountability forms according to the
      contents of the envelopes.

      A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope.
      During the standard anterior approach procedure, an anesthesiologist administered fentanyl or
      hydromorphone as needed for analgesia. The local anesthetics were administered after
      reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc
      0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control
      group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle,
      the local anesthetics were injected using a deep tissue administration technique. Structures
      innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve
      were considered suitable for injection. Throughout administration, frequent aspirations were
      performed to check for blood and minimize the risk of intravascular injection. The patients,
      surgical team, and floor staff was blinded to the local anesthetic drugs given.

      During hospitalization, patients were observed, evaluated and treated according to
      postoperative protocols. Patients received opioids for pain management as needed, which was
      routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone,
      codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine
      equivalent dosages for analysis. Each patient began physical therapy within the first 24
      hours postoperatively. Patients were discharged when they were able to begin self-care, their
      pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication
      intake.
    

Intervention name(s): Liposomal Bupivacaine; 0.25% Bupivacaine with epinephrine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 266mg liposomal bupivacaine; 0.25% bupivacaine with epinephrine; Normal saline
Other intervention name(s): Exparel; Marcaine; Saline solution
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exparel; total hip replacement; bupivacaine