Function and Pain Following Knee Replacement

NCT ID: NCT05478005

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-07-21

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.

Conditions

Knee Arthropathy; Post Operative Pain; Pain, Postoperative

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Femoral nerve block

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

Group Type: EXPERIMENTAL

Femoral nerve block

Intervention Type: 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.

Intra-articular block

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

Group Type: EXPERIMENTAL

Intra-articular block

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Femoral 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.

Intervention Type: PROCEDURE

Intra-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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Michal Elboim

Full-time lecturer and faculty member in the Physical Therapy Department at the University of Haifa (UOH)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haim Shtarker, Dr

Role: PRINCIPAL_INVESTIGATOR

Head of the orthopedic department, Galilee medical center

Locations

Galilee medical center

Nahariya, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 40388473 (View on PubMed)

Other Identifiers

UHaifa-MEGK

Identifier Type: -

Identifier Source: org_study_id