Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Total Knee Arthroplasty; Adductor Canal Block
• Intervention / Treatment: Procedure: Multimodal Peripheral Nerve Block Injection; Drug: Initial Bolus; Drug: Continuous infusion; Procedure: Single Shot Adductor Canal Block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous adductor canal block; After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 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. Multimodal peripheral nerve block injection.	Procedure: Multimodal Peripheral Nerve Block Injection; 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.; Other Names: adductor canal catheter bolus and continuous infusion; Drug: Initial Bolus; 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine; Drug: Continuous infusion; Continuous infusion of 0.125% bupivacaine
Sham Comparator: Single injection block with sham cath; Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.	Drug: Initial Bolus; 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine; Procedure: Single Shot Adductor Canal Block; 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.; Other Names: adductor canal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	At 30 hours pain scores between the two groups will be compared for determining statistically significant differences	30 hours post block placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total opioid consumption	The amount of total opioid consumed will be collected	Through 30 hours post block

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Jonathan D Jaffe, D.O., Dr.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): November 15, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB00041950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No