Adductor Canal Block for Total Knee Arthroplasty

NCT02453360 | Completed Results

• 1 other identifier: 2014-1419
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. However, few studies have carefully evaluated the impact of volume of injection of local anesthetic into the adductor canal on motor weakness or pain control. The ability to achieve similar pain control with decreased volumes of local anesthetic would allow the surgery team to apply more local anesthetic to posterior knee structures. Decreased volumes of local anesthetic may also be associated with a decreased risk of local anesthetic toxicity. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, the investigators hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of volume of injection of local anesthetic into the adductor canal on motor strength.

Conditions

Arthroplasty, Replacement, Knee; Pain, Postoperative

Keywords

Anesthesia; Analgesia

Outcome Measures

Primary Outcomes (1)

• 10 Meter Walk Test

  This will be evaluated by determining how quickly a patient is able to ambulate over 10 meters on POD 1 (10 meter walk test).

  24 hours postoperatively following total knee arthroplasty

Secondary Outcomes (4)

• Opioid Consumption

  PACU Discharge through 24 hours postoperatively

• Pain With Activity at 24 Hours

  24 Hours Following Surgery

• Percentage Change in Knee Extension Strength From Baseline

  24 Hours Following Surgery

• Number of Participants With Nausea at 24 Hours

  Perioperative through 48 hours postoperatively

Study Arms (3)

5 ml

EXPERIMENTAL

Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.

Procedure: Adductor Canal Block; Drug: Adductor Canal Block

10 ml

EXPERIMENTAL

Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.

Procedure: Adductor Canal Block; Drug: Adductor Canal Block

20 ml

EXPERIMENTAL

Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.

Procedure: Adductor Canal Block; Drug: Adductor Canal Block

Interventions

Adductor Canal Block PROCEDURE

Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.

10 ml; 20 ml; 5 ml

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is scheduled for elective unilateral TKA
• The subject is ≥ 18 years and ≤ 80 years;
• The subject's weight is between 70-120 kg; and
• The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural).
• The patient agrees to receive an adductor canal block.
• American Society of Anesthesiologists class 1-3

You may not qualify if:

• Subject is \< 18 years of age or \>80 years of age;
• Subject is non-English speaking;
• Subject is known or believed to be pregnant;
• Subject is a prisoner;
• Subject has impaired decision-making capacity; per discretion of the Investigator
• Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
• Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
• Significant pre-existing neuropathy on the operative limb;
• Significant renal, cardiac or hepatic disease per discretion of the investigator.
• American Society of Anesthesiologists class 4-5
• Known hypersensitivity and/or allergies to local anesthetics
• Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Kristopher Schroeder
• Organization: University of Wisconsin School of Medicine

kmschro1@wisc.edu

608-263-8100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 25, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-08

Locations

US (1)