Function and Pain Following Knee Replacement

NCT05478005 | Completed

• 1 other identifier: UHaifa-MEGK
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  first and fifth day after the surgery

• 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.

  first and fifth day after the surgery

• 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.

  first and fifth day after the surgery

• Change in Numeric pain rating scale

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

  up to five days

• Chane in Quadriceps muscle strength

  muscle strength measure by dynamometer (N⋅m)

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

Secondary Outcomes (4)

• Hospitalization duration

  At discharge (assessed up to day 10)

• Surgery duration

  During the surgery

• consumption of analgesics

  At discharge (assessed up to day 10)

• occurrence of falls

  At discharge (assessed up to day 10)

Other Outcomes (1)

• Oxford knee score questionnaire

  A 1 day before the surgery

Study Arms (3)

Femoral nerve block

EXPERIMENTAL

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

Procedure: Femoral nerve block

Intra-articular block

EXPERIMENTAL

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

Procedure: Intra-articular block

Control group

NO INTERVENTION

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

Interventions

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.

Femoral nerve block

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.

Intra-articular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
• ASA score 1-3

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Haifa: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (1)

Galilee medical center

Nahariya, Israel

Location

Related Publications (1)

• Kliger-Tendler M, Elboim-Gabyzon M, Bathish E, Shtarker H. Assessing Functional Outcomes and Pain Intensity Variations After Total Knee Arthroplasty: A Comparative Analysis of Pain Block Techniques. J Am Acad Orthop Surg Glob Res Rev. 2025 May 13;9(5):e24.00323. doi: 10.5435/JAAOSGlobal-D-24-00323. eCollection 2025 May 1.

  PMID: 40388473 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Haim Shtarker, Dr

  Head of the orthopedic department, Galilee medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor who was blinded to the treatment group allocation and who was not involved in the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time lecturer and faculty member in the Physical Therapy Department at the University of Haifa (UOH)

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 28, 2022
• Study Start: November 1, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)