Total Knee ArthroplastyNCT05390450
Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block After Total Knee Arthroplasty
A study testing Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Fascia Iliaca block in people with Total Knee Arthroplasty and Popliteal Plexus Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty, Popliteal Plexus Block, Fascia Iliaca Block
- What is being tested?
- Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Fascia Iliaca block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 31 Mar 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 - 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) score I-II.
- Scheduled for unilateral, primary TKA under spinal anesthesia.
Who cannot join
- Coagulopathy.
- Diabetes.
- Obesity.
- Heart failure.
- kidney failure.
- Liver failure.
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- Reduced sensation on the lower limb.
- Daily intake of opioids.
- Contraindication to any drug used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial
This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.
Read the detailed description
The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus.
Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.
- Being tested
- Ultrasound-Guided Popliteal Plexus Block, Ultrasound-Guided Fascia Iliaca block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Popliteal Plexus BlockDevice
Patients in this group will receive Popliteal plexus block. Prior to Popliteal plexus block, the proximal end of the adductor canal will be identified. The transducer will be slid distally along the femoral artery until the artery deviated away from the sartorius muscle in the distal part of the adductor canal towards the adductor hiatus. The nerve block needle will be inserted from the anterolateral end of the transducer and advanced in-plane through the medial vastus muscle. The endpoint of injection will be inside the distal end of the adductor canal close to the adductor hiatus. The injection will be adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle. The Popliteal plexus block will be carried out with 10 mL of local anesthetic mixture, containing 50 mg of bupivacaine and 0.05 mg of epinephrine.
Ultrasound-Guided Fascia Iliaca blockDevice
Patients will be placed in a supine position, and the skin will be cleaned aseptically. The inguinal ligament from the anterior superior iliac spine to the pubic tubercle will be drawn on the skin and divided into 3 parts. The injection point was 1 cm caudally from the point where the lateral and middle part of the inguinal ligament met. The skin and deep tissues were infiltrated with 1% lidocaine. A 18G nerve block needle will be inserted into the skin perpendicularly until the first (fascia lata) and second loss of resistance (fascia iliaca) will be felt. Following aspiration to exclude intravascular injection, 40 mL of 0.25% bupivacaine (1-1.5 mg/kg), which will be prepared under aseptic conditions, and then injected. Sensorial block will be evaluated using the pinprick test 20 minutes after injection for areas of the thigh innervated by the femoral, lateral cutaneous and obturator nerves.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Popliteal Plexus Block | Experimental | Patients in this group will receive Popliteal plexus block. Receives: Device: Ultrasound-Guided Popliteal Plexus Block |
| Ultrasound-Guided Fascia Iliaca block | Experimental | Patients in this group will receive Fascia Iliaca block. Receives: Device: Ultrasound-Guided Fascia Iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous (IV) morphine consumption
Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.
Measured: 24 hours postoperatively.
Secondary outcomes (4)
First analgesic request
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg).
Measured: 24 hours postoperatively
Pain level score
Pain levels using the numerical rating scale (NRS) of pain intensity (0 = no pain) to (10 = intolerable pain), pain relief is defined as a NRS of 3 or lower. If the score is >3, the patient will need analgesia in the form of morphine 0.05 mg/kg till it decreases to ≤3. NRS will be assessed and recorded on arrival to Post-Anesthesia Care Unit , 1, 2, 4, 8, 12 and 24 hours postoperatively at rest and on movement (knee flexion) during the first postoperative 24 hours.
Measured: 24 hours postoperatively
Rehabilitation
Rehabilitation (time to ability to sit, time to ability to stand, time to ability to walk, Time to ability to do exercise) will be recorded.
Measured: 24 hours postoperatively
Patient's satisfaction level
Degree of patient satisfaction will be assessed on a 5-point scale; (1= highly satisfied, 2 = satisfied, 3 = neither satisfied nor unsatisfied, 4 = not satisfied, 5 = highly not satisfied)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taysser Mahmoud Abdalraheem, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390450
- Sponsor's protocol ID
- 35431/4/22
- Status last verified
- Apr 2023
- First submitted
- 18 May 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol will available under reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Popliteal Plexus Block Versus Fascia Iliaca Block for Postoperative Analgesia After Total Knee Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05390450
- Acronym / sponsor ID
- 35431/4/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 May 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.
This study aims to investigate the effect of the Popliteal Plexus Block versus Fascia Iliaca Block on postoperative pain after total knee arthroplasty.
Detailed description
The Popliteal Plexus entwines the popliteal artery and vein contiguous to the adductor hiatus in the popliteal fossa and innervates the posterior capsule as well as intraarticular genicular structures. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the Popliteal Plexus.
Recently, fascia iliaca block was proposed as a popular analgesic technique which involves local infiltration anesthesia under the fascia of the iliacus muscle. The method depends on the local anesthetics spread beneath the fascia to block the peripheral nerve. It has been proposed to avoid the complications by anesthetizing the femoral nerve remotely from major neurovascular structures and achieve adequate analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Popliteal Plexus Block | Experimental | Device: Ultrasound-Guided Popliteal Plexus BlockPatients in this group will receive Popliteal plexus block. |
| Ultrasound-Guided Fascia Iliaca block | Experimental | Device: Ultrasound-Guided Fascia Iliaca blockPatients in this group will receive Fascia Iliaca block. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 - 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) score I-II.
- Scheduled for unilateral, primary TKA under spinal anesthesia.
Key exclusion criteria (9 listed)
- Coagulopathy.
- Diabetes.
- Obesity.
- Heart failure.
- kidney failure.
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 |
|---|---|---|
| Ultrasound-Guided Popliteal Plexus BlockPatients in this group will receive Popliteal plexus block. Prior to Popliteal plexus block, the proximal end of the adductor canal will be identified. The transducer will be slid distally along the femoral artery until the artery deviated away from the sartorius muscle in the distal part of the adductor canal towards the adductor hiatus. The nerve block needle will be inserted from the anterolateral end of the transducer and advanced in-plane through the medial vastus muscle. The endpoint of injection will be inside the distal end of the adductor canal close to the adductor hiatus. The injection will be adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle. The Popliteal plexus block will be carried out with 10 mL of local anesthetic mixture, containing 50 mg of bupivacaine and 0.05 mg of epinephrine. | Device | Ultrasound-Guided Popliteal Plexus Block |
| Ultrasound-Guided Fascia Iliaca blockPatients will be placed in a supine position, and the skin will be cleaned aseptically. The inguinal ligament from the anterior superior iliac spine to the pubic tubercle will be drawn on the skin and divided into 3 parts. The injection point was 1 cm caudally from the point where the lateral and middle part of the inguinal ligament met. The skin and deep tissues were infiltrated with 1% lidocaine. A 18G nerve block needle will be inserted into the skin perpendicularly until the first (fascia lata) and second loss of resistance (fascia iliaca) will be felt. Following aspiration to exclude intravascular injection, 40 mL of 0.25% bupivacaine (1-1.5 mg/kg), which will be prepared under aseptic conditions, and then injected. Sensorial block will be evaluated using the pinprick test 20 minutes after injection for areas of the thigh innervated by the femoral, lateral cutaneous and obturator nerves. | Device | Ultrasound-Guided Fascia Iliaca block |
Primary outcome
Total intravenous (IV) morphine consumption
Time frame: 24 hours postoperatively.
Total intravenous (IV) morphine consumption during the first postoperative 24 hours, postoperatively.
4 secondary outcomes
First analgesic request
Time frame: 24 hours postoperatively
Pain level score
Time frame: 24 hours postoperatively
Rehabilitation
Time frame: 24 hours postoperatively
Patient's satisfaction level
Time frame: 24 hours postoperatively
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 21 Apr 2023.
- Individual participant dataSharing planned: Yes. The protocol will available under reasonable request from the corresponding author.
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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 Ultrasound-Guided Popliteal Plexus Block and Ultrasound-Guided Fascia Iliaca block in people with Total Knee Arthroplasty and Popliteal Plexus Block, run by Tanta University at 1 site in Egypt.
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 4 inclusion and 9 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 21 Apr 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 Egypt. 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?
Total intravenous (IV) morphine consumption (time frame: 24 hours postoperatively.). 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 21 Apr 2023.