Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
Condition: Total Knee Arthroplasty; Pain, Postoperative; Adductor Canal Block
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either
      multimodal single injection adductor canal block with sham infusion catheter or continuous
      infusion of local anesthetic (control) for postoperative analgesia.

      Primary end point is pain scores at 30 hours post performance of block procedure.
    

Detailed description: 
      The objective of this study is to determine if a single shot multimodal peripheral nerve
      block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will
      provide comparable (equivalent) analgesic control when compared to an adductor catheter. The
      primary end point will be pain scores at 30 hours post block initiation. Secondary end points
      will include, opioid consumption, time to first analgesic request; pain scores; binary
      patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg
      raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative
      nausea, and vomiting.

      Methods and Measures Design The study will be a randomized, double-blind, sham catheter
      study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm"
      receive a single shot adductor canal block containing 20 milliliters (ml) of solution
      including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of
      clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in
      the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm.
      The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in
      the current pump in use at our hospital). An opaque bag will be placed over the pump for
      blinding purposes. The "Control Arm" will receive an adductor canal catheter through which
      they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by
      an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will
      be placed over the control arm pumps in similar fashion. For all patients, the order in the
      electronic medical record will be per research pharmacy protocol. For their primary
      anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic
      or general anesthetic per the anesthesiologist in the operating room.
    

Intervention name(s): Multimodal Peripheral Nerve Block Injection; Single Shot Adductor Canal Block; Initial Bolus; Continuous infusion
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.; A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.; 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine; Continuous infusion of 0.125% bupivacaine
Other intervention name(s): adductor canal catheter bolus and continuous infusion; adductor canal block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment