Risk of Falling After CFNB Versus ACB

NCT02314832 | Completed DMC

• 1 other identifier: 820115
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve plays an important role in pain control after total knee replacement. However, femoral nerve block has been associated with increased risk of falls due to weakness of the thigh muscle. This prospective, randomized controlled trial asks the question whether blocking the more distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block, and thus less risk of falls. The study also aims to compare pain control after both techniques.

Conditions

Falls; Total Knee Arthroplasty (TKA); Osteoarthritis

Keywords

femoral nerve block; adductor canal block; tinetti score; 2- Results to time to up and go (TUG ) test; 3- Results to Tinetti test; 4- Ambulation distance; 5- Pain scores at rest and with movement

Outcome Measures

Primary Outcomes (1)

• risk of falling score

  The percentage of patients at high risk of falls as evaluated by Tinetti score in both groups. Scores of 19 or less are usually associated with higher risk of falls.

  24 hours after surgery

Secondary Outcomes (1)

• Pain scores

  48 hours

Study Arms (2)

Continuous femoral nerve block

ACTIVE COMPARATOR

patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty

Procedure: femoral nerve block

adductor canal block

ACTIVE COMPARATOR

adductor canal block group will receive adductor canal block for analgesia after TKA

Procedure: adductor canal block

Interventions

adductor canal block PROCEDURE

ultrasound guided saphenous nerve block in the adductor canal

adductor canal block

femoral nerve block PROCEDURE

ultrasound guided femoral nerve block

Continuous femoral nerve block

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for primary total knee arthroplasty
• American Society of Anesthesiologists (ASA) physical status I -III
• mentally competent and able to give consent for enrollment in the study

You may not qualify if:

• Patient younger than 18 years old
• Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
• Revision surgery will be excluded.
• Impaired kidney functions and patient with coagulopathy will also be excluded.
• Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery.
• BMI of 40 or more
• Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nabil M Elkassabany, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: December 11, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)