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

NCT02991404 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB00041950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Pain, Postoperative; Adductor Canal Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total opioid consumption

  Through 30 hours post block

Study Arms (2)

Continuous adductor canal block

ACTIVE COMPARATOR

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; Drug: Initial Bolus; Drug: Continuous infusion

Single injection block with sham cath

SHAM COMPARATOR

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.

Procedure: Single Shot Adductor Canal Block; Drug: Initial Bolus

Interventions

Multimodal Peripheral Nerve Block Injection PROCEDURE

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.

Also known as: adductor canal catheter bolus and continuous infusion

Continuous adductor canal block

Single Shot Adductor Canal Block PROCEDURE

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.

Also known as: adductor canal block

Single injection block with sham cath

Initial Bolus DRUG

20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine

Continuous adductor canal block; Single injection block with sham cath

Continuous infusion DRUG

Continuous infusion of 0.125% bupivacaine

Continuous adductor canal block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jonathan D Jaffe, D.O.

  Dr.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 13, 2016
• Study Start: February 17, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)