Knee ArthropathyNCT05478005
Function and Pain Following Knee Replacement
A study testing Femoral nerve block and Intra-articular block in people with Knee Arthropathy and Post Operative Pain, run by University of Haifa at 1 site in Israel.
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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthropathy, Post Operative Pain, Pain, Postoperative
- What is being tested?
- Femoral nerve block and Intra-articular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2022to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
- ASA score 1-3
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief
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.
Read the 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
- Being tested
- Femoral nerve block, Intra-articular block
- Keywords
- post operative pain, total knee replacement, total knee arthroplasty, pain, post operative function, nerve block, intra-articular block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block | Experimental | Patients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure. Receives: Procedure: Femoral nerve block |
| Intra-articular block | Experimental | Patients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure. Receives: Procedure: Intra-articular block |
| Control group | No intervention | Patients undergoing total knee arthroplasty and didn't receive pain block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to five days
Chane in Quadriceps muscle strength
muscle strength measure by dynamometer (N⋅m)
Measured: A 1 day before the surgery, first and fifth day after the surgery.
Secondary outcomes (4)
Hospitalization duration
Number of days of hospitalization after the surgery- taken from the patient's file
Measured: At discharge (assessed up to day 10)
Surgery duration
minutes- taken from the patient's file
Measured: During the surgery
consumption of analgesics
taken from the patient's file
Measured: At discharge (assessed up to day 10)
occurrence of falls
throughout the hospitalization- taken from the patient's file
Measured: At discharge (assessed up to day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Nov 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Responsible party
- Principal investigator, Michal Elboim, University of Haifa
- Investigators
- Haim Shtarker, Dr, Principal investigator, Head of the orthopedic department, Galilee medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478005
- Sponsor's protocol ID
- UHaifa-MEGK
- Status last verified
- Oct 2023
- First submitted
- 4 Jul 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40388473
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Function and Pain Intensity in the Acute Stage Following Total Knee Replacement, Between Different Methods of Post-surgical Pain Relief
- ClinicalTrials.gov ID
- NCT05478005
- Acronym / sponsor ID
- UHaifa-MEGK
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block | Experimental | Procedure: Femoral nerve blockPatients undergoing total knee arthroplasty received a single-shot femoral nerve block during the surgical procedure. |
| Intra-articular block | Experimental | Procedure: Intra-articular blockPatients undergoing total knee arthroplasty received a intra-articular block during the surgical procedure. |
| Control group | No intervention | –Patients undergoing total knee arthroplasty and didn't receive pain block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women, over the age of 18, electively assigned for primary knee replacement surgery.
- ASA score 1-3
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral nerve blockPatients 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. | Procedure or surgery | Femoral nerve block |
| Intra-articular blockPatients 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. | Procedure or surgery | Intra-articular block |
Primary outcome
Change in Timed up & go test
Time frame: 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 Elderly mobility scale
Time frame: 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 5 times sit to stand test
Time frame: 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
Time frame: 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
Time frame: A 1 day before the surgery, first and fifth day after the surgery.
muscle strength measure by dynamometer (N⋅m)
4 secondary outcomes
Hospitalization duration
Time frame: At discharge (assessed up to day 10)
Surgery duration
Time frame: During the surgery
consumption of analgesics
Time frame: At discharge (assessed up to day 10)
occurrence of falls
Time frame: At discharge (assessed up to day 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 40388473Kliger-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haim Shtarker, Dr principal investigator
Head of the orthopedic department, Galilee medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block and Intra-articular block in people with Knee Arthropathy and Post Operative Pain, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Timed up & go test (time frame: first and fifth day after the surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.