Clinical trial NCT05478005: Function and Pain Following Knee Replacement
Official title: Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Western Galilee Hospital-Nahariya
First posted: 2022-07-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Timed up & go test
timeFrame: first and fifth day after the surgery
measure: Change in Elderly mobility scale
timeFrame: first and fifth day after the surgery
measure: Change in 5 times sit to stand test
timeFrame: first and fifth day after the surgery
measure: Change in Numeric pain rating scale
timeFrame: up to five days
measure: Chane in Quadriceps muscle strength
timeFrame: A 1 day before the surgery, first and fifth day after the surgery.
Secondary outcomes:
measure: Hospitalization duration
timeFrame: At discharge (assessed up to day 10)
measure: Surgery duration
timeFrame: During the surgery
measure: consumption of analgesics
timeFrame: At discharge (assessed up to day 10)
measure: occurrence of falls
timeFrame: At discharge (assessed up to day 10)
Other outcomes:
measure: Oxford knee score questionnaire
timeFrame: A 1 day before the surgery
Locations:
city: Nahariya
country: Israel
facility: Galilee medical center
Study officials:
affiliation: Head of the orthopedic department, Galilee medical center
name: Haim Shtarker, Dr
role: PRINCIPAL_INVESTIGATOR
References: