Clinical trial NCT02991404: Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
Official title: Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Total Knee Arthroplasty
Pain, Postoperative
Adductor Canal Block
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Patients will be eligible for inclusion in the study if they are:

* Age of 18 years old or older
* Scheduled to primary unilateral total knee arthroplasty.
* Patients must give written informed consent for anesthesia including continuous adductor canal block for postoperative analgesia prior to recruitment

Exclusion Criteria:

Patients will be excluded if they have:

* A contraindication to an adductor canal block or catheter placement including, but not limited to site infection, irritation, or refusal.
* Poorly controlled diabetes (A1C \>8.0)
* Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine, clonidine, or dexamethasone)
* Opioid use \>40 mg of oxycodone daily, long-acting opioids.

Primary outcomes:
measure: Pain scores
timeFrame: 30 hours post block placement
Secondary outcomes:
measure: total opioid consumption
timeFrame: Through 30 hours post block
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
Study officials:
affiliation: Dr.
name: Jonathan D Jaffe, D.O.
role: PRINCIPAL_INVESTIGATOR
References: