AzTrials
AzTrials

Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle SurgeriesPhase 4NCT06744010

Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries

A Phase 4 study testing Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries in people with Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019). It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where… Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
What is being tested?
Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteEgypt
Study dates
5 Jun 2024to 5 Nov 2024
Phase
Phase 4
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 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1. Adult patients who will be scheduled to undergo surgery on medial side of the ankle, or both sides of the ankle (Achilles tendon surgery, the removal of an implanted device on the medial side, or ankle arthroscopy) under peripheral nerve blocks (PNBs).
  • 2. Patients have an American Society of Anesthesiologists Physical status of I to II.
  • 3. Age 19 to 65 years.

Who cannot join

  • 1. An inability of patient to cooperate. 2. A history of alcohol or drug abuse. 3. Those with rheumatoid arthritis, coagulation disorders, peripheral neuropathy.
  • 4. Known allergies to local anesthetics. 5. Recent use of opioids, corticosteroids, or any other analgesics. 6. If a patient complained of incomplete block before the end of surgery, we will exclude the patient from the analysis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University Hospital

    Al Fayyum, 63514

Other trials in Egypt

About this study

Ankle surgeries are severely painful. A sciatic nerve block is typically not enough to cover the pain sources (Delbos et al., 2019).

It can be speculated that approaching the saphenous nerve in the subsartorial compartment distal to the point where it pierces the vastoadductor membrane but proximal to the point where it penetrates the crural fascia and becomes subcutaneous would selectively target the saphenous nerve without any decrease of quadriceps strength (Jensen et al., 2024).

Read more

Previous study showed that femoral nerve block (FNB) provides good surgical anesthesia and good postoperative pain control for patients with ankle conditions (Lee et al., 2014). However, FNB leads to femoral quadriceps muscle weakness (Jaeger et al., 2013).

Consequently, quadriceps weakness results in functional impairment and it is associated with an increased risk of postoperative falls (Johnson et al., 2013).

Thus far, attempts to reduce quadriceps involvement after FNB without compromising analgesia have not been successful (Li et al., 2019).

Partially because of the increase in the use of ultrasound guidance, a more targeted approach that only blocks sensory fibers of the femoral nerve that supply the operative site has been attempted; thus, the feasibility of sub sartorial canal block has been studied (Kopp et al., 2017).

In recent years, sub sartorial canal block has been successfully used for postoperative pain control after knee surgery (Lavand'homme et al., 2022).

However, no randomized, control study has compared sub sartorial canal block to femoral nerve block for ankle surgeries. We hypothesized that compared to femoral nerve block, sub sartorial canal block would demonstrate noninferior pain scores during surgery and until 48 hours postoperatively and cause less weakness in the quadriceps.

Read the detailed description

Sample size was calculated using Power Analysis and Sample Size Software (PASS 2020) "NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass". Based on a previously published study (Lavand'homme et al., 2022) and (Joe et al., 2016); the VAS pain scores of the adductor canal block group were not inferior during and after the operation compared to those of the FNB group. At 30 minutes and 2 hours after anesthesia, patients who received an adductor canal block had significantly higher average dynamometer readings than those who received a FNB (34.2±20.4 and 30.4±23.7 vs 1.7±3.7 and 2.3±7.4, respectively), and the results were similar at 24 and 48 hours after anesthesia. Based on this, a minimal total hypothesized sample size of 60 eligible patients will be needed taking into consideration 95% level of confidence, an effect size of 1/100 and 5% margin of error using two-sided proportional Z- test. Sample size will be increased 20% for possible dropout rate, so 72 patients will be enrolled in the study (36 in each group).

  • Randomization: It will be based on a computer-generated block randomization list (4 numbers per block) in a 1:1 ratio. All patients underwent sub sartorial canal block + popliteal block, or femoral block + popliteal block according to a randomized assignment . the randomization sequence was kept hidden in sealed opaque envelopes. After recruitment and admittance to blocking room , the authors unwrapped the envelopes . the allocations of the group were blinded to assessors , data collectors with an expert anesthesiologist doing the block (single blinded).
  • Study tools:
  1. After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.
  2. A total of 72 patients will be categorized into 2 groups:
  • Group A "sub sartorial canal block + popliteal block".
  • Group B "femoral block + popliteal block".
  1. Anesthesia and postoperative analgesia:
  • All patients will be anesthetized with PNBs for surgery.
  • PNBs will be performed in a block room at least 30minute preoperatively.
  • All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
  • All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
  • A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
  • The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
  • The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
  • For the ultrasound-guided sub sartorial compartment block of the saphenous nerve, the patient will be placed in the supine position with external rotation of the thigh and slight flexion of the knee. A 15 MHz linear ultrasound probe (PX, FUJIFILM SonoSite, Bothell, Washington, USA) will be placed in the transverse plane across the sartorius muscle approximately at the base of the patella. The sartorius muscle will be followed proximally and distally in order to visualize the segment of the sub sartorial compartment between the two points where the saphenous nerve intersected the tendons of the adductor magnus and semimembranosus muscles, respectively. The saphenous nerve will be visualized in the proximal half of this segment of the subsartorial compartment - just distal to the intersection of the saphenous nerve and the tendon of the adductor magnus muscle. At this level there is a well-defined subsartorial compartment between the sartorius muscle tendon and the so-called 'subsartorial fat pad' that is compliant for injection. The needle will be inserted ultrasound-guided in-plane from anterior to posterior and advanced in order to place the needle tip adjacent to the saphenous nerve and inject perineurally.
  • For popliteal sciatic nerve block, the patient will be lain laterally on the opposite side of the limb which has to be blocked. The limb to be blocked will be flexed partially at hip and knee joint. Using a high-frequency linear probe, a scan of popliteal fossa will be conducted to identify separate tibial and common peroneal nerves lying superficially and posteriorly to popliteal artery. Movement of the probe proximally brings tibial and common peroneal nerves together to form the sciatic nerve at a variable point, above the popliteal crease. At this level, via out-of plane technique, using 21 gauge insulated needle, 20 ml of 0.5% ropivacaine will be deposited after negative aspiration and real-time spread of local anesthetic will be visualized in sub paraneural space around the sciatic nerve.
  • For the femoral nerve block, the femoral nerve will be identified lateral to the femoral artery at the inguinal crease in the transverse section. The study medication will be injected anterior and posterior to the nerve.
  1. The actual or estimated needle insertion sites will be covered with a dressing bandage in all patients to blind those assessing the outcome of the procedure to the treatment.
  2. Intravenous ketorolac tromethamine (30mg, maximum dose 90mg/d) will be given as a rescue analgesic during the first 48 hours postoperatively when a patient reported a visual analog scale (VAS) score of ≥5 or if the patient requested pain relief.
  3. All the patients will receive 0.03 mg/kg of intra-venous midazolam and oxygen will be supplied by face mask throughout the procedure.
  4. Surgery will be started after adequate sensory and motor blockade will be achieved.
  5. In patients with failure to achieve adequate surgical anesthesia after 20 minutes of administration of block, it will be considered as a block failure and converted to general anesthesia.
Being tested
Sub sartorial canal block and popliteal block in ankle surgeries, femoral block and popliteal block in ankle surgeries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sub sartorial canal block and popliteal block in ankle surgeriesProcedure or surgery

    All patients will be anesthetized with PNBs for surgery.

    • PNBs will be performed in a block room at least 30minute preoperatively.
    • All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
    • All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
    • A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
    • The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
    • The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
  • femoral block and popliteal block in ankle surgeriesProcedure or surgery

    • All patients will be anesthetized with PNBs for surgery.
    • PNBs will be performed in a block room at least 30minute preoperatively.
    • All PNBs will be performed under ultrasound guidance (LOGIQ P6, GE Healthcare; Chicago, IL) using a high-frequency linear transducer (3.4-10.8MHz).
    • All blocks will be performed after skin preparation with 2% chlorhexidine gluconate by 1 orthopedic surgeon (YUP) with vast experience in ultrasound-guided nerve block techniques.
    • A 22-ga Tuohy needle will be introduced in-plane and 2 to 3mL of saline will be used to confirm the correct position of the needle tip near the target nerve.
    • The study medication will be administered through the needle as a bolus of 20mL of a 1:1 mixed solution of bupivacaine 0.75% and lidocaine 1%.
    • The total volume per every block will be 20 ml in the form of bupivacaine 1.25% with 1:200,000 epinephrine and 250 mg Mgso4.
Study groups in NCT06744010
Study groupRoleWhat they receive
Group AExperimentalsub sartorial canal block + popliteal block
Receives: Procedure: Sub sartorial canal block and popliteal block in ankle surgeries
Group BExperimentalfemoral block + popliteal block
Receives: Procedure: femoral block and popliteal block in ankle surgeries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue score

    Visual analogue score at 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively

    Measured: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively

Secondary outcomes (9)
  1. • Quadriceps muscle power.

    • Quadriceps muscle power.

    Measured: In the first 48 hours after surgery.

  2. Number of patients requiring analgesic rescue in the first 48 hours after surgery.

    Number of patients requiring analgesic rescue in the first 48 hours after surgery.

    Measured: In the first 48 hours after surgery.

  3. Total opioid consumption.

    Total opioid consumption.

    Measured: In the first 48 hours after surgery.

  4. Duration of the procedure

    Duration of the procedure

    Measured: In the first 48 hours

  5. Time to full anesthesia

    Time to full anesthesia

    Measured: 20 to 30 minutes before surgery

  6. Operative time

    Operative time

    Measured: 6 hours

  7. Recovery time

    Recovery time

    Measured: 48 hours after surgery

  8. Patient satisfaction questionnaire

    Patient satisfaction

    Measured: In the first 48 hours after surgery

  9. Incidence of complications

    Incidence of complications

    Measured: In the first 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start5 Jun 2024
  3. Primary completion5 Sep 2024
  4. Study completion5 Nov 2024

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06744010
Sponsor's protocol ID
M 739
Status last verified
Dec 2024
First submitted
12 Dec 2024
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.

    PubMed 31663286
  • Kopp SL, Borglum J, Buvanendran A, Horlocker TT, Ilfeld BM, Memtsoudis SG, Neal JM, Rawal N, Wegener JT. Anesthesia and Analgesia Practice Pathway Options for Total Knee Arthroplasty: An Evidence-Based Review by the American and European Societies of Regional Anesthesia and Pain Medicine. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):683-697. doi: 10.1097/AAP.0000000000000673.

    PubMed 29053504
  • Joe HB, Choo HS, Yoon JS, Oh SE, Cho JH, Park YU. Adductor canal block versus femoral nerve block combined with sciatic nerve block as an anesthetic technique for hindfoot and ankle surgery: A prospective, randomized noninferiority trial. Medicine (Baltimore). 2016 Dec;95(52):e5758. doi: 10.1097/MD.0000000000005758.

    PubMed 28033291
  • Jensen AE, Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Vaeggemose M, Bendtsen TF. Distal subsartorial compartment block of the saphenous nerve - A dissection study and a patient case series. J Clin Anesth. 2024 Feb;92:111315. doi: 10.1016/j.jclinane.2023.111315. Epub 2023 Nov 3.

    PubMed 37926063
  • Delbos A, Philippe M, Clement C, Olivier R, Coppens S. Ultrasound-guided ankle block. History revisited. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):79-93. doi: 10.1016/j.bpa.2019.05.002. Epub 2019 May 7.

    PubMed 31272656

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sub sartorial canal block and popliteal block in ankle surgeries and femoral block and popliteal block in ankle surgeries in people with Sub Sartorial Canal Block and Popliteal Block Versus Femoral Block and Popliteal Block in Ankle Surgeries, run by Fayoum University Hospital 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 3 inclusion and 2 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 20 Dec 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visual analogue score (time frame: 15 minute after the block then at skin incision and "2, 6, 12, 24, and 48 hours postoperatively). 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 NCT06744010, which also lists 5 linked publications.

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 20 Dec 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in