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Modified TIPS Block for Total Knee Arthroplasty

ConditionsKnee ArthropathyAnesthesia, Local
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAlexandria University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia

    Procedure/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 block

    Procedure/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 block

    Procedure/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 analgesia

    Procedure/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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Modified TIPS BlockExperimental treatment 3 interventions
Group B: TIPS BlockActive comparator 3 interventions

Trial outcomes

Primary outcomes

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

Time frame
24 hours

Secondary outcomes

1

The time to the 1st demand dose of rescue analgesia

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

Time frame
24 hours
2

Resting and dynamic VAS assessment

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

Time frame
24 hours
3

Timed Up and Go (TUG) test

Timed Up and Go (TUG) test

Time frame
24 hours
4

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

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

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: