search
Back to results

Function and Pain Following Knee Replacement

Primary Purpose

Knee Arthropathy, Post Operative Pain, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Femoral nerve block
Intra-articular block
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring post operative pain, total knee replacement, total knee arthroplasty, pain, post operative function, nerve block, intra-articular block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Galilee medical center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Femoral nerve block

Intra-articular block

Control group

Arm Description

Patients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure.

Patients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure.

Patients undergoing total knee arthroplasty and didn't receive pain block.

Outcomes

Primary Outcome Measures

Change in 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.
Change in Elderly mobility scale
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.
Change in 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.
Change in Numeric pain rating scale
An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
Chane in Quadriceps muscle strength
muscle strength measure by dynamometer (N⋅m)

Secondary Outcome Measures

Hospitalization duration
Number of days of hospitalization after the surgery- taken from the patient's file
Surgery duration
minutes- taken from the patient's file
consumption of analgesics
taken from the patient's file
occurrence of falls
throughout the hospitalization- taken from the patient's file

Full Information

First Posted
July 4, 2022
Last Updated
October 18, 2023
Sponsor
University of Haifa
Collaborators
Western Galilee Hospital-Nahariya
search

1. Study Identification

Unique Protocol Identification Number
NCT05478005
Brief Title
Function and Pain Following Knee Replacement
Official Title
Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Western Galilee Hospital-Nahariya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Post Operative Pain, Pain, Postoperative
Keywords
post operative pain, total knee replacement, total knee arthroplasty, pain, post operative function, nerve block, intra-articular block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor who was blinded to the treatment group allocation and who was not involved in the interventions.
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral nerve block
Arm Type
Experimental
Arm Description
Patients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure.
Arm Title
Intra-articular block
Arm Type
Experimental
Arm Description
Patients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients undergoing total knee arthroplasty and didn't receive pain block.
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intra-articular block
Intervention Description
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 Outcome Measure Information:
Title
Change in Timed up & go test
Description
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.
Time Frame
first and fifth day after the surgery
Title
Change in Elderly mobility scale
Description
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.
Time Frame
first and fifth day after the surgery
Title
Change in 5 times sit to stand test
Description
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.
Time Frame
first and fifth day after the surgery
Title
Change in Numeric pain rating scale
Description
An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
Time Frame
up to five days
Title
Chane in Quadriceps muscle strength
Description
muscle strength measure by dynamometer (N⋅m)
Time Frame
A 1 day before the surgery, first and fifth day after the surgery.
Secondary Outcome Measure Information:
Title
Hospitalization duration
Description
Number of days of hospitalization after the surgery- taken from the patient's file
Time Frame
At discharge (assessed up to day 10)
Title
Surgery duration
Description
minutes- taken from the patient's file
Time Frame
During the surgery
Title
consumption of analgesics
Description
taken from the patient's file
Time Frame
At discharge (assessed up to day 10)
Title
occurrence of falls
Description
throughout the hospitalization- taken from the patient's file
Time Frame
At discharge (assessed up to day 10)
Other Pre-specified Outcome Measures:
Title
Oxford knee score questionnaire
Description
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.
Time Frame
A 1 day before the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Shtarker, Dr
Organizational Affiliation
Head of the orthopedic department, Galilee medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galilee medical center
City
Nahariya
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Function and Pain Following Knee Replacement

We'll reach out to this number within 24 hrs