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Anesthesia, LocalPhase 4NCT06096584

TIPS Block vs Dual Subsartorial Block

A Phase 4 study testing Triple Injection Perisartorius block, Dual sub sartorial block and Femoral triangle block in people with Anesthesia, Local and Knee Arthropathy, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The present study examines adding local anesthetic injection superior to the sartorius at the level of the femoral triangle to block the intermediate femoral cutaneous nerve (IFCN) which is responsible for the innervation of the anterior thigh and the proximal part of the parapatellar incision used for total knee… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Anesthesia, Local, Knee Arthropathy
What is being tested?
Triple Injection Perisartorius block, Dual sub sartorial block and Femoral triangle block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteEgypt
Study dates
Dec 2023to Jul 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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for unilateral total knee arthroplasty

Who cannot join

  • BMI > 35 kg/m2
  • Pre-existing neurological deficit
  • Any disability of the non-operated limb preventing fair mobilization
  • Infection at the site of injection
  • Chronic opioid users/abusers

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria Faculty of Medicine

    Alexandria, 21651

Other trials in Egypt

About this study

Official title: TIPS Block vs Dual Subsartorial Block for Total Knee Arthrolplasty: Double Blinded Randomized Controlled Study

The present study examines adding local anesthetic injection superior to the sartorius at the level of the femoral triangle to block the intermediate femoral cutaneous nerve (IFCN) which is responsible for the innervation of the anterior thigh and the proximal part of the parapatellar incision used for total knee arthroplasty (TKA). This may provide superior analgesia when added to dual subsartorial blockade in cases of total knee arthroplasty

Read the detailed description

Introduction: Maximum pain control with regional analgesic techniques after total knee arthroplasty (TKA) is crucial for early rehabilitation after surgery. The ideal regional anesthetic technique should cover all the essential innervations of the knee joint involved in each surgical step without causing motor blockade.

The investigators hypothesize that local anesthetic injection superior to the sartorius at the level of the femoral triangle may block the intermediate femoral cutaneous nerve (IFCN) which is responsible for the innervation of the anterior thigh and the proximal part of the parapatellar incision used for TKA and provide superior analgesia when added to dual subsartorial blockade in cases of TKA.

Patients will be divided into 2 groups. Group TIPS; patients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA). Group Dual; patients will receive double level subsartorial canal block after induction of GA.

Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Induction of anesthesia will be carried out with 2 mic/kg fentanyl, 2 mg/kg propofol and 25 mg atracurium followed by insertion of a proper size laryngeal mask airway (LMA). Patients will be randomly allocated into 2 groups by a computer generated program.

Group Dual: Patients will receive a combination of femoral triangle block and distal ACB. Femoral triangle block will be given just 1-2 cm proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially.

Group TIPS: Patients will receive dual injection subsartorial block and a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata.

Postoperatively, multimodal analgesia regimen will be continued in the form of paracetamol 1 g /8 hours and ketorolac 30 mg /8 hours intravenously for 24 hours. Intravenous morphine patient controlled analgesia will be started after induction of GA at a concentration of 0.5 mg/ml without a background infusion on demand dose of 1 mg with a lockout interval of 10 minutes. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 hour follow up period. Total postoperative morphine requirements will be measured during the postoperative follow up period. Postoperative functional outcome will be assessed using the Timed Up and Go (TUG) test and the 30-second Chair Stand Test (30s-CST).

Being tested
Triple Injection Perisartorius block, Dual sub sartorial block, Femoral triangle block, Distal adductor canal block, Suprasartorial plane block

What participants receive

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

  • Triple Injection Perisartorius blockProcedure or surgery

    Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone.

    Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata

  • Dual sub sartorial blockProcedure or surgery

    Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone

    Patients will receive a combination of femoral triangle block and distal ACB.

  • Femoral triangle blockProcedure or surgery

    Femoral triangle block will be given just (1-2 cm) proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM.

  • Distal adductor canal blockProcedure or surgery

    Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal.

  • Suprasartorial plane blockProcedure or surgery

    Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata

Study groups in NCT06096584
Study groupRoleWhat they receive
Group TIPSExperimentalpatients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA)
Receives: Procedure: Triple Injection Perisartorius block; Procedure: Femoral triangle block; Procedure: Distal adductor canal block; Procedure: Suprasartorial plane block
Group DualActive comparatorpatients will receive double level subsartorial canal block after induction of GA
Receives: Procedure: Dual sub sartorial block; Procedure: Femoral triangle block; Procedure: Distal adductor canal block

What is being measured

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

  1. Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain

    Resting visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

    Measured: 1st 24 hours after surgery

Secondary outcomes (4)
  1. Postoperative dynamic visual analogue scale score. It's a 0-10 score where 0 is no pain and 10 is the worst pain

    Dynamic visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

    Measured: 1st 24 hours after surgery

  2. Total postoperative morphine requirements

    Measured: 1st 24 hours after surgery

  3. Postoperative functional outcome

    Timed Up and Go (TUG) test. Score < 10s indicates normal mobility

    Measured: 1st 24 hours after surgery

  4. Postoperative functional outcome

    30-second Chair Stand Test (30s-CST). The number of times the patient can stand and sit in 30 seconds

    Measured: 1st 24 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 posted24 Oct 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionJul 2024 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blinded randomized controlled study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096584
Sponsor's protocol ID
0306191
Status last verified
Oct 2023
First submitted
12 Oct 2023
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request

Publications

  • Ishiguro S, Yokochi A, Yoshioka K, Asano N, Deguchi A, Iwasaki Y, Sudo A, Maruyama K. Technical communication: anatomy and clinical implications of ultrasound-guided selective femoral nerve block. Anesth Analg. 2012 Dec;115(6):1467-70. doi: 10.1213/ANE.0b013e31826af956. Epub 2012 Aug 10.

    PubMed 22886842
  • Ludwigson JL, Tillmans SD, Galgon RE, Chambers TA, Heiner JP, Schroeder KM. A Comparison of Single Shot Adductor Canal Block Versus Femoral Nerve Catheter for Total Knee Arthroplasty. J Arthroplasty. 2015 Sep;30(9 Suppl):68-71. doi: 10.1016/j.arth.2015.03.044. Epub 2015 Jun 3.

    PubMed 26129851

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Triple Injection Perisartorius block, Dual sub sartorial block and Femoral triangle block in people with Anesthesia, Local and Knee Arthropathy, run by Alexandria 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 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 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?

Results are not available in the source record.

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?

Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain (time frame: 1st 24 hours after surgery). 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 NCT06096584, which also lists 2 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 27 Oct 2023.

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