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Knee ArthropathyPhase 4NCT06539910

Modified TIPS Block for Total Knee Arthroplasty

A Phase 4 study testing General Anesthesia, TIPS block and Modified TIPS block in people with Knee Arthropathy and Anesthesia, Local, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA) Read more about this study

Who is it for?
Any age
Conditions the study is for
Knee Arthropathy, Anesthesia, Local
What is being tested?
General Anesthesia, TIPS block and Modified TIPS block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
Aug 2024to Mar 2025
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status I-III

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: Modified Triple Injection Peri-Sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA)

The is carried out to compare triple injection peri-sartorial block to a modified block including an extra local anesthetic injection deep to the adductor longs muscle via a medial to lateral approach regarding the peri-operative analgesia following total knee arthroplasty (TKA)

Read the detailed description

We hypothesise that LA injection at a plane deep to adductor longus muscle at the level of femoral triangle may block the 2 divisions of the ON and improve analgesia following TKA. Moreover, the medial to lateral needle trajectory may avoid NVM injury.

Aim of the work: The primary aim of this study is to determine if addition of LA injection underneath the ALM targeting ON divisions to tri-injection perisartorius (TIPS) block, may decrease the postoperative opioid rescue analgesic requirements after TKA.

The secondary aim of this study is to investigate the effect of addition of LA injection under the ALM to TIPS block on the resting and dynamic VAS scores during the 1st 24 h postoperative period. The secondary aims include the time to the 1st request of rescue analgesia, the motor power of the operated limb as well as any complication related to the block technique.

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 90 patients scheduled for unilateral TKA. Based on a pilot study, a total sample size of 90 participants - 45 patients in TIPS group and 45 patients in mTIPS group - is needed to achieve 80% power and to detect difference of 0.6 mg in the mean of morphine consumption between the two groups with group standard deviations of 1 Using t test (a two-sided two-sample t-test) at a significance level of 05. Sample size was calculated using NCSS 2004 and PASS 2000 program. Informed written consent will be signed by all patients. The visual analogue scale (VAS) score interpretation and the use of patient controlled analgesia (PCA) device will be explained to all participants. 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 randomised into 2 groups using a closed envelope technique:

Group TIPS: patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection.

Group MTIPS: patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.

Both groups will receive distal adductor canal block via another needle puncture.

All blocks will be performed after induction of general anaesthesia (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. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients

Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal. The total volume of LA will be determined according to group selection:

Group TIPS: Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery. Then, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 40 mL.

Group MTIPS: Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM). Again, the needle will be redirected to perform the suprasartorial plane injection. Total volume of LA will be 50 mL.

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 at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. The time to the 1st demand dose of rescue analgesia will be recorded. Resting and dynamic VAS assessment will be carried out every 4 hours during the 24 h follow up period. Total postoperative morphine requirements will be measured during the 24 h 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) in the evening of the day of surgery.

Being tested
General Anesthesia, TIPS block, Modified TIPS block, Mutimodal analgesia
Keywords
Analgesia, arthroplasty, knee replacement, nerve block, peri-sartorial block, triple injection, visual analogue scale
Medical subject headings
Agnosia

What participants receive

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

  • General AnesthesiaProcedure or surgery

    All blocks will be performed after induction of general anaesthesia (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. Controlled GA via a laryngeal mask airway (LMA) will be done to all patients

  • TIPS blockProcedure or surgery

    Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection. Distal adductor canal block via another needle puncture.Ten mL of a mixture of 0.25 % bupivacaine and 8 mg dexamethasone will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane lateral to medial approach just lateral to the superficial femoral artery

  • Modified TIPS blockProcedure or surgery

    Patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane.Both groups will receive a mixture of 0.25 % bupivacaine and 8 mg dexamethasone. Ten mL will be injected in the suprasartorial plane and 20 mL will be injected at the distal adductor canal.Ten mL of the LA anaesthetic mixture will be injected 2 cm above the FT apex via ultrasound guided in-plane medial to lateral approach just lateral to the superficial femoral artery. Then, the needle will be redirected just underneath the ALM and 10 mL of the LA mixture will be injected in the plane between the ALM and the adductor magnus muscle (AMM).Total volume of LA will be 50 mL.

  • Mutimodal analgesiaProcedure or surgery

    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 at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes

Study groups in NCT06539910
Study groupRoleWhat they receive
Modified TIPS BlockExperimentalModified Triple Injection Peri-sartorial Block Patients will receive ultrasound guided single puncture triple injections through medial to lateral approach. LA will be injected at the distal FT lateral to the superficial femoral artery (FA), deep to adductor longus muscle (ALM), and at the supra-sartorial plane
Receives: Procedure: General Anesthesia; Procedure: TIPS block; Procedure: Mutimodal analgesia
TIPS BlockActive comparatorTriple Injection Peri-sartorial Block Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection
Receives: Procedure: General Anesthesia; Procedure: Modified TIPS block; Procedure: Mutimodal analgesia

What is being measured

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

  1. Postoperative opioid rescue analgesic requirements

    Intravenous morphine patient controlled analgesia will be started at the end of surgery at a concentration of 0.5 mg/ml without a background infusion on a demand dose of 1 mg with a lockout interval of 10 minutes. Total postoperative morphine consumption will be measured

    Measured: 24 hours

Secondary outcomes (4)
  1. The time to the 1st demand dose of rescue analgesia

    The time to the 1st demand dose of rescue analgesia will be recorded

    Measured: 24 hours

  2. Resting and dynamic VAS assessment

    Resting and dynamic VAS assessment will be carried out every 4 hours

    Measured: 24 hours

  3. Timed Up and Go (TUG) test

    Timed Up and Go (TUG) test

    Measured: 24 hours

  4. 30-second Chair Stand Test (30s-CST)

    30-second Chair Stand Test (30s-CST)

    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 posted6 Aug 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionFeb 2025 (estimated)
  4. Study completionMar 2025 (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
Randomized controlled study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539910
Sponsor's protocol ID
0306646
Status last verified
Aug 2024
First submitted
2 Aug 2024
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be shared upon request via mail to the principal investigator

Publications

  • Woodworth GE, Arner A, Nelsen S, Nada E, Elkassabany NM. Pro and Con: How Important Is the Exact Location of Adductor Canal and Femoral Triangle Blocks? Anesth Analg. 2023 Mar 1;136(3):458-469. doi: 10.1213/ANE.0000000000006234. Epub 2023 Feb 17.

    PubMed 36806233

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing General Anesthesia, TIPS block and Modified TIPS block in people with Knee Arthropathy and Anesthesia, Local, 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 1 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: status not confirmed, as of the sponsor's last update on 6 Aug 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact moustafa Abdelaziz, MD (1222373407 ext. +20, m.3abdelaziz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative opioid rescue analgesic requirements (time frame: 24 hours). 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 NCT06539910, which also lists 1 linked publication.

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 6 Aug 2024.

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