Total Knee ArthroplastyNCT06196359
Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block
A study testing Combined Femoral and Popliteal nerve block in people with Total Knee Arthroplasty and Total Knee Replacement, run by University of Haifa at 1 site in Israel.
Trial summary
The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Replacement, Total Knee Replacement Surgery
- What is being tested?
- Combined Femoral and Popliteal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2022to 14 Aug 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
- Over the age of 18
- Electively assigned for primary knee replacement surgery.
- The American Society of Anesthesiologists physical status 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
The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:
Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement, Total Knee Replacement Surgery, Arthritis Knee, Rehabilitation
- Being tested
- Combined Femoral and Popliteal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Femoral and Popliteal nerve blockProcedure or surgery
Patients who receive a combined femoral and popliteal 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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Femoral and Popliteal nerve block | Experimental | Patients who receive a Patients undergoing total knee arthroplasty received a combined femoral and popliteal nerve block (single-shot of each) during the surgical procedure. Receives: Procedure: Combined Femoral and Popliteal nerve 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.
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 day after surgery and third or fourth day after surgery
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 four days after surgery
Quadriceps Muscle Strength
muscle strength measure by dynamometer (N⋅m)
Measured: A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .
Secondary outcomes (7)
Elderly Mobility Scale
The Elderly Mobility Scale is a 20 point validated assessment tool for the assessment of frail elderly subjects. The The Elderly Mobility Scale is measured on an ordinal scale of 0-20, when Scores under 10 - generally these patients are dependent in mobility maneuvers; require help with basic activity of daily living, such as transfers, toileting and dressing. Scores between 10 - 13 - generally these patients are borderline in terms of safe mobility and independence in activity of daily living i.e. they require some help with some mobility maneuvers. Scores over 14 - Generally these patients are able to perform mobility maneuvers alone and safely and are independent in basic activity of daily living.
Measured: First day after the surgery and third or fourth day after the surgery
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 day after the surgery and third or fourth day after the surgery
Hospitalization Duration
Number of days of hospitalization after the surgery- taken from the pa...
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)
Oxford Knee Score Questionnaire
The Oxford Knee Score is a patient self-completion patient-reported outcome 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 Oxford Knee Score 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.
Measured: A 1 day before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Nov 2022
- Primary completion14 Jul 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196359
- Sponsor's protocol ID
- UHaifa-FPNB
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block
- ClinicalTrials.gov ID
- NCT06196359
- Acronym / sponsor ID
- UHaifa-FPNB
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement, Total Knee Replacement Surgery, Arthritis Knee, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 9 Jan 2024 (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 examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:
Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Femoral and Popliteal nerve block | Experimental | Procedure: Combined Femoral and Popliteal nerve blockPatients who receive a Patients undergoing total knee arthroplasty received a combined femoral and popliteal nerve block (single-shot of each) 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 (3 listed)
- Over the age of 18
- Electively assigned for primary knee replacement surgery.
- The American Society of Anesthesiologists physical status 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 |
|---|---|---|
| Combined Femoral and Popliteal nerve blockPatients who receive a combined femoral and popliteal 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 | Combined Femoral and Popliteal nerve block |
Primary outcome
Timed up & go Test
Time frame: First day after surgery and third or fourth day after 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.
Numeric Pain Rating Scale
Time frame: up to four days after surgery
An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
Quadriceps Muscle Strength
Time frame: A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .
muscle strength measure by dynamometer (N⋅m)
7 secondary outcomes
Elderly Mobility Scale
Time frame: First day after the surgery and third or fourth day after the surgery
5 Times Sit to Stand Test
Time frame: First day after the surgery and third or fourth day after the surgery
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)
Oxford Knee Score Questionnaire
Time frame: A 1 day before the surgery
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 12 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Femoral and Popliteal nerve block in people with Total Knee Arthroplasty and Total Knee Replacement, 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 3 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 12 Jan 2024. 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?
Timed up & go Test (time frame: First day after surgery and third or fourth day after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.