Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block

The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:

Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Total Knee Arthroplasty; Total Knee Replacement; Arthritis Knee; Total Knee Replacement Surgery
• Intervention / Treatment: Procedure: Combined Femoral and Popliteal nerve block

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 22000
    • Galilee Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over the age of 18
• Electively assigned for primary knee replacement surgery.
• The American Society of Anesthesiologists physical status score 1-3.

Exclusion Criteria:

• Revision surgery.
• Patients suffering from chronic pain syndrome or chronic opioid use.
• Patients with previous neurological deficits in the lower extremities.
• A cognitive state that does not allow signing of consent or understanding simple instructions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients undergoing total knee arthroplasty and didn't receive pain block.
Experimental: Combined Femoral and Popliteal nerve block; Patients who receive a Patients undergoing total knee arthroplasty received a combined femoral and popliteal nerve block (single-shot of each) during the surgical procedure.	Procedure: Combined Femoral and Popliteal nerve block; Patients who receive a combined femoral and popliteal nerve block during surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up & go Test	Total time to arise from chair, walk 3 m, turn around, return to chair and sit down. Two trials performed and the faster of the two is recorded to the nearest 10th of a second.	First day after surgery and third or fourth day after surgery
Numeric Pain Rating Scale	An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable	up to four days after surgery
Quadriceps Muscle Strength	muscle strength measure by dynamometer (N⋅m)	A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elderly Mobility Scale	The Elderly Mobility Scale is a 20 point validated assessment tool for the assessment of frail elderly subjects. The The Elderly Mobility Scale is measured on an ordinal scale of 0-20, when Scores under 10 - generally these patients are dependent in mobility maneuvers; require help with basic activity of daily living, such as transfers, toileting and dressing. Scores between 10 - 13 - generally these patients are borderline in terms of safe mobility and independence in activity of daily living i.e. they require some help with some mobility maneuvers. Scores over 14 - Generally these patients are able to perform mobility maneuvers alone and safely and are independent in basic activity of daily living.	First day after the surgery and third or fourth day after the surgery
5 Times Sit to Stand Test	The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.	First day after the surgery and third or fourth day after the surgery
Hospitalization Duration	Number of days of hospitalization after the surgery- taken from the pa...	At discharge (assessed up to day 10)
Surgery Duration	minutes- taken from the patient's file	During the surgery
Consumption of Analgesics	taken from the patient's file	At discharge (assessed up to day 10)
Occurrence of Falls	throughout the hospitalization- taken from the patient's file	At discharge (assessed up to day 10)
Oxford Knee Score Questionnaire	The Oxford Knee Score is a patient self-completion patient-reported outcome containing 12 questions on activities of daily living. It provides a single summed score which reflects the severity of problems that the respondent has with their knee. The Oxford Knee Score is scored 0-48 when Score 0-19 May indicate severe knee arthritis. Score 20-29 May indicate moderate to severe knee arthritis. Score 30-39 May indicate mild to moderate knee arthritis. Score 40-48 May indicate satisfactory joint function.	A 1 day before the surgery

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: UHaifa-FPNB

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