Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial

NCT02773537 | Completed Results

• 1 other identifier: Pro00042461
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Pain Measurement Via VAS (Visual Analog Scale)

  The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.

  48 hours after procedure

Secondary Outcomes (7)

• Narcotic Requirements

  48 hours after procedure

• Functional Outcome Measures- Exstension/Knee Buckling

  1-2 days after procedure

• Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)

  Morning of post-op day 1 - 2 days after procedure

• Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked

  Morning of post-op day 1 - 2 days after procedure

• Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds

  Morning of post-op day 1 - 2 days after procedure

Study Arms (3)

Randomization Group 1

ACTIVE COMPARATOR

Femoral nerve catheter and sciatic nerve block

Drug: Femoral nerve catheter and sciatic nerve block

Randomization Group 2

ACTIVE COMPARATOR

Adductor canal catheter and selective tibial block

Drug: Adductor canal catheter and selective tibial block

Randomization Group 3

ACTIVE COMPARATOR

Adductor canal catheter only

Drug: Adductor canal catheter only

Interventions

Femoral nerve catheter and sciatic nerve block DRUG

This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Randomization Group 1

Adductor canal catheter and selective tibial block DRUG

This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Randomization Group 2

Adductor canal catheter only DRUG

This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb

Randomization Group 3

Eligibility Criteria

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

You may qualify if:

• Males and Females 18 years of age or older
• Undergoing elective primary total knee arthroplasty
• Patient is willing and able to give consent and participate

You may not qualify if:

• Inability to receive spinal anesthesia or peripheral nerve block
• Non-ambulatory patients
• Non- English speaking patients
• Vulnerable populations including prisoners

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Results Point of Contact

• Title: Dr. Eric Bolin
• Organization: Medical University of South Carolina

bolin@musc.edu

843-792-2322

Study Officials

• Jacob Drew, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 16, 2016
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 27, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Locations

US (1)