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Completed

NCT Number: NCT06196359

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.

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Key information

Conditions

Total Knee Arthroplasty Arthritis Knee Rehabilitation Total Knee Replacement Total Knee Replacement Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galilee Medical Centre

Nahariya, 22000, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Femoral and Popliteal nerve block

Procedure

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.

Primary outcomes

  1. Timed up & go Test

    Time frame: First day after surgery and third or fourth day after surgery

    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.

  2. Numeric Pain Rating Scale

    Time frame: up to four days after surgery

    An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable

  3. Quadriceps Muscle Strength

    Time frame: A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .

    muscle strength measure by dynamometer (N⋅m)

Secondary outcomes

  1. Elderly Mobility Scale

    Time frame: First day after the surgery and third or fourth day after the surgery

    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.

  2. 5 Times Sit to Stand Test

    Time frame: First day after the surgery and third or fourth day after the surgery

    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.

  3. Hospitalization Duration

    Time frame: At discharge (assessed up to day 10)

    Number of days of hospitalization after the surgery- taken from the pa...

  4. Surgery Duration

    Time frame: During the surgery

    minutes- taken from the patient's file

  5. Consumption of Analgesics

    Time frame: At discharge (assessed up to day 10)

    taken from the patient's file

  6. Occurrence of Falls

    Time frame: At discharge (assessed up to day 10)

    throughout the hospitalization- taken from the patient's file

  7. Oxford Knee Score Questionnaire

    Time frame: A 1 day before the surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Western Galilee Hospital-Nahariya

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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