Function and Pain Following Knee Replacement

Not Applicable

Completed

• Conditions: Knee Arthropathy; Pain, Postoperative; Post Operative Pain
• Interventions: Procedure: Femoral nerve block; Procedure: Intra-articular block

• Registration Number: NCT05478005
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-28
• Study Start: 2022-11-01
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block	Femoral nerve block	Patients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure.
Intra-articular block	Intra-articular block	Patients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure.

Primary Outcome Measures

Name	Time	Method
Change in Elderly mobility scale	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.
Change in Timed up & go test	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.
Change in 5 times sit to stand test	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.
Change in Numeric pain rating scale	up to five days	An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
Chane in Quadriceps muscle strength	A 1 day before the surgery, first and fifth day after the surgery.	muscle strength measure by dynamometer (N⋅m)

Secondary Outcome Measures

Name	Time	Method
Hospitalization duration	At discharge (assessed up to day 10)	Number of days of hospitalization after the surgery- taken from the patient's file
Surgery duration	During the surgery	minutes- taken from the patient's file
occurrence of falls	At discharge (assessed up to day 10)	throughout the hospitalization- taken from the patient's file
consumption of analgesics	At discharge (assessed up to day 10)	taken from the patient's file

Trial Locations

Locations (1)

Galilee medical center; 🇮🇱 Nahariya, Israel