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Knee DiseaseNCT05289427

Triple Injection Peri-sartorius (TIPS) Block

A study testing ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block in people with Knee Disease and Nerve Pain, run by Alexandria University 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
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Trial summary

Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB) Read more about this study

Who is it for?
Any age
Conditions the study is for
Knee Disease, Nerve Pain
What is being tested?
ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Apr 2022to 7 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • BMI > 35 kg/m2, Pre-existing neurological deficit, Any disability of the non-operated limb preventing fair mobilization, Known contraindications to peripheral nerve block (coagulopathy or 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: Triple Injection Peri-sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA): Randomised Controlled Study

Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)

Read the detailed description

Introduction: Adequate pain control, along with quadriceps muscle preservation, has become a goal among orthopedic departments following TKA(1). The femoral nerve block (FNB) has been for many years the gold standard analgesic therapy for TKA however, it leads to quadriceps weakness(2).

Subsartorial block has been originally prescribed to block sensation in the front and the medial aspect of the knee with little quadriceps weakness (3). Local anaesthetic (LA) injected at the distal third of the adductor canal may enter into the popliteal region along with the femoral vessels to involve the popliteal plexus which supplies the posterior knee joint capsule (4). The anterior femoral cutaneous nerve (AFCN) is the overall term for the intermediate femoral cutaneous nerves (IFCNs) and the medial femoral cutaneous nerve (MFCN). The MFCN innervates the distal medial thigh as well as the anteromedial knee region. It may be anesthetized in the proximal part of the femoral triangle. The IFCN innervates the distal anterior thigh, which includes the proximal part of the surgical incision for TKA. They can be ultrasonographically identified and targeted in the subcutaneous plane on the anterior thigh where they pierce the fascia lata (FL) anterior to the sartorius muscle (SAM) before they ramify in multiple branches(5).

We hypothesize that injection of LA at the femoral triangle level above and below the sartorius muscle and at the distal end of the adductor canal may provide superior analgesia to femoral nerve block alone with little quadriceps weakness in TKA.

Aim of the study: The primary aim of this study is to compare the visual analogue scale scores during the 1st 24 postoperative hours after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB.

The secondary aims of this study are to compare the total postoperative opioid (morphine) consumption, evaluate the effect of the two techniques on the motor power of the operated limb and to detect any complications related to the block or opioids used.

Methods: After obtaining approval from Alexandria university ethics committee, this study will be carried out in El-Hadara university hospital on American Society of Anesthesiologists (ASA) physical status I-III 80 patients scheduled for unilateral TKA. A total sample size of 80 patients, 40 in each group will be sufficient to provide more than 80 % power at a two sided 0.05 significance level. The exclusion criteria will include; BMI > 35 kg/m2, pre-existing neurological deficit, any disability of the non-operated limb preventing fair mobilization, known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), or chronic opioid users/abusers.

Patients will be divided into 2 groups. Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision. Group FNB; patients will receive femoral nerve block (FNB) before surgical incision.

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. Plan of anaesthesia will be determined by the anesthesiologist in charge. After induction of general anaesthesia or administration of spinal anaesthesia, patients will be randomly divided by a closed envelope method into two groups:

Group TIPS: Patients will receive a combination of supra-sartorius plane block, femoral triangle block and distal ACB. Ten ml of 0.25 % bupivacaine will be injected. 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. The needle will be withdrawn subcutaneously and another 10 ml of local anesthetic will be injected above the sartorius and below the fascia lata (5). 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.(6) Group FNB: Patients will receive single injection of 20 ml 0.25 % bupivacaine mixed with 4 mg dexamethasone about 2 cm below the inguinal ligament. LA mixture will be injected under the fascia iliaca just lateral to the femoral nerve. The femoral artery at this level will appear as a single vessel before bifurcation into profunda femoris and superficial femoral artery.

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 at a dose of 0.05 mg/kg will be given as a rescue analgesic when the VAS ≥4. 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.

Rehabilitation through physical therapy will be performed by patients during the 24 hour follow up period. Ambulation distances from both morning and evening sessions will be combined into a total ambulatory distance for comparative purposes. Active postoperative knee extension while patients are in seated position will be normalized into degrees of flexion (90°-0°). Physical therapy data will be obtained from physical therapy notes. Postoperative complications related to opioid usage like nausea and vomiting or related to the block like neurological symptoms or falls will be recorded. Postoperative patient satisfaction will be recorded after 24 hours.

Being tested
ultrasound guided triple injection peri-sartorius block, Femoral Nerve Block
Medical subject headings
Neuralgia

What participants receive

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

  • ultrasound guided triple injection peri-sartorius blockProcedure or surgery

    Patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision

  • Femoral Nerve BlockProcedure or surgery

    Patients will receive femoral nerve block (FNB) before surgical incision

Study groups in NCT05289427
Study groupRoleWhat they receive
TIPS BlockExperimentalGroup TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision
Receives: Procedure: ultrasound guided triple injection peri-sartorius block
FNBActive comparatorGroup FNB; patients will receive femoral nerve block (FNB) before surgical incision
Receives: Procedure: Femoral Nerve Block

What is being measured

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

  1. Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)

    Compare the two groups regarding the visual analogue scale scores

    Measured: 24 hours postoperatively

Secondary outcomes (3)
  1. Total postoperative morphine consumption

    Compare the total postoperative opioid (morphine) consumption after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB

    Measured: 24 hours postoperatively

  2. Operated limb motor power

    Compare the two groups regarding the operated limb motor power

    Measured: 24 hours postoperatively

  3. Complications

    Compare the two groups regarding complications of the two techniques and opioid related side effects

    Measured: 24 hours

Timeline

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

  1. First posted21 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion7 Mar 2023
  4. Study completion7 Mar 2023

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289427
Sponsor's protocol ID
0305449
Status last verified
Mar 2023
First submitted
13 Mar 2022
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the resultsrepoted in this article after deidentification (text, tables, figures, and appendices)

Questions about this trial

What is this clinical trial studying?

A study testing ultrasound guided triple injection peri-sartorius block and Femoral Nerve Block in people with Knee Disease and Nerve Pain, 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 0 inclusion and 1 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 10 Mar 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?

Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain) (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 10 Mar 2023; AzTrials last refreshed its copy on 27 Oct 2026.

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