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Function and Pain Following Knee Replacement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05478005
Enrollment
54
Registered
2022-07-28
Start date
2022-11-01
Completion date
2023-07-21
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthropathy, Pain, Postoperative, Post Operative Pain

Keywords

post operative pain, total knee replacement, total knee arthroplasty, pain, post operative function, nerve block, intra-articular block

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.

Interventions

PROCEDUREFemoral nerve block

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.

PROCEDUREIntra-articular block

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.

Sponsors

Western Galilee Hospital-Nahariya
CollaboratorOTHER_GOV
University of Haifa
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor who was blinded to the treatment group allocation and who was not involved in the interventions.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Chane in Quadriceps muscle strengthA 1 day before the surgery, first and fifth day after the surgery.muscle strength measure by dynamometer (N⋅m)
Change in Timed up & go testfirst and fifth day after the surgeryTotal 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 scalefirst and fifth day after the surgeryThe 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 testfirst and fifth day after the surgeryThe 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 scaleup to five daysAn 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable

Secondary

MeasureTime frameDescription
Hospitalization durationAt discharge (assessed up to day 10)Number of days of hospitalization after the surgery- taken from the patient's file
Surgery durationDuring the surgeryminutes- taken from the patient's file
consumption of analgesicsAt discharge (assessed up to day 10)taken from the patient's file
occurrence of fallsAt discharge (assessed up to day 10)throughout the hospitalization- taken from the patient's file

Other

MeasureTime frameDescription
Oxford knee score questionnaireA 1 day before the surgeryThe 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026