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Completed

NCT Number: NCT05478005

Function and Pain Following Knee Replacement

The goal of this interventional study is to compare pain management techniques (femoral nerve block, intra-articular block, none) in TKA patients. The main questions it aims to answer are:

* Are there differences in postoperative outcomes? * Does preoperative quadriceps muscle strength predict early functional ability? Participants underwent TKA and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative quadriceps muscle strength as a predictor of early functional ability. Further research is required to refine postoperative pain management strategies.

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Key information

Conditions

Knee Arthropathy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galilee medical center

Nahariya, Israel

About this study

Total knee arthroplasty (TKA) is a frequently undertaken elective orthopedic intervention for severe knee osteoarthritis, frequently yielding postoperative discomfort and complications. Peripheral nerve blocks, notably femoral nerve blocks, are commonly utilized for analgesia but may transiently impede motor nerve function, weakening the quadriceps muscle. Intra-articular blocks offer a potential alternative to mitigate motor impairment. However, there exists a dearth of information regarding the comparative effectiveness of these methods with respect to short-term functional outcomes in the immediate postoperative phase following TKA.

Objectives: This study assesses functional outcomes, pain, quadriceps strength after TKA with femoral nerve block, intra-articular block, and a control group. It identifies predictors of postoperative functional ability.

Methods: 54 patients undergoing TKA were evaluated, measuring pre-op quadriceps strength, and utilizing the Oxford Knee Score for functionality. Post-op, we evaluated mobility using the Timed Up & Go, Elderly Mobility Scale, and Five Times Sit-to-Stand tests on POD 1 & 3/4. Pain levels, hospitalization, surgical duration, complications, and falls were also recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
  • ASA 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

Femoral Nerve Block

Procedure

Patients who receive a femoral 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.

Intra-articular block

Procedure

Patients who receive an intra-articular block at the time of 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. Change in Timed up & go test

    Time frame: first and fifth day after the 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. Change in Elderly mobility scale

    Time frame: first and fifth day after the surgery

    The EMS is a 20 point validated assessment tool for the assessment of frail elderly subjects. The EMS is measured on an ordinal scale of 0-20, when Scores under 10 - generally these patients are dependent in mobility manoeuvres; require help with basic ADL, such as transfers, toileting and dressing. Scores between 10 - 13 - generally these patients are borderline in terms of safe mobility and independence in ADL i.e. they require some help with some mobility manoeuvres.

    Scores over 14 - Generally these patients are able to perform mobility manoeuvres alone and safely and are independent in basic ADL.

  3. Change in 5 times sit to stand test

    Time frame: first and fifth 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.

  4. Change in Numeric pain rating scale

    Time frame: up to five days

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

  5. Chane in Quadriceps muscle strength

    Time frame: A 1 day before the surgery, first and fifth day after the surgery.

    muscle strength measure by dynamometer (N⋅m)

Secondary outcomes

  1. Hospitalization duration

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

    Number of days of hospitalization after the surgery- taken from the patient's file

  2. Surgery duration

    Time frame: During the surgery

    minutes- taken from the patient's file

  3. consumption of analgesics

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

    taken from the patient's file

  4. occurrence of falls

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

    throughout the hospitalization- taken from the patient's file

Other outcomes

  1. Oxford knee score questionnaire

    Time frame: A 1 day before the surgery

    The OKS is a patient self-completion PRO 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 OKS 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

Official study title

Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2022
Registry last updated
Oct 23, 2023

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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