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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06196359
Other study ID # UHaifa-FPNB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date August 14, 2023

Study information

Verified date December 2023
Source University of Haifa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 14, 2023
Est. primary completion date July 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Israel Galilee Medical Centre Nahariya

Sponsors (2)

Lead Sponsor Collaborator
University of Haifa Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary Hospitalization Duration Number of days of hospitalization after the surgery- taken from the pa... At discharge (assessed up to day 10)
Secondary Surgery Duration minutes- taken from the patient's file During the surgery
Secondary Consumption of Analgesics taken from the patient's file At discharge (assessed up to day 10)
Secondary Occurrence of Falls throughout the hospitalization- taken from the patient's file At discharge (assessed up to day 10)
Secondary 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
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