Function and Pain Following Knee Replacement

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478005
• Other study ID #: UHaifa-MEGK
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: October 2023
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthropathy
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Galilee medical center	Nahariya

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxford knee score questionnaire	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.	A 1 day before the surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Hospitalization duration	Number of days of hospitalization after the surgery- taken from the patient's file	At discharge (assessed up to day 10)
Secondary	Surgery duration	minutes- taken from the patient's file	During the surgery
Secondary	consumption of analgesics	taken from the patient's file	At discharge (assessed up to day 10)
Secondary	occurrence of falls	throughout the hospitalization- taken from the patient's file	At discharge (assessed up to day 10)