Modified TIPS Block for Total Knee Arthroplasty

NCT06539910 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 0306646
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Knee Arthropathy; Anesthesia, Local

Keywords

Analgesia, arthroplasty, knee replacement, nerve block, peri-sartorial block, triple injection, visual analogue scale

Outcome Measures

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

  24 hours

Secondary Outcomes (4)

• The time to the 1st demand dose of rescue analgesia

  24 hours

• Resting and dynamic VAS assessment

  24 hours

• Timed Up and Go (TUG) test

  24 hours

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

  24 hours

Study Arms (2)

Modified TIPS Block

EXPERIMENTAL

Modified 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

Procedure: General Anesthesia; Procedure: TIPS block; Procedure: Mutimodal analgesia

TIPS Block

ACTIVE COMPARATOR

Triple Injection Peri-sartorial Block Patients will receive distal FTB through conventional lateral to medial approach, in addition to a supra-sartorial plane injection

Procedure: General Anesthesia; Procedure: Modified TIPS block; Procedure: Mutimodal analgesia

Interventions

General Anesthesia PROCEDURE

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

Modified TIPS Block; TIPS Block

TIPS block PROCEDURE

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

Modified TIPS block PROCEDURE

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.

TIPS Block

Mutimodal analgesia PROCEDURE

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

Modified TIPS Block; TIPS Block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36806233 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

moustafa Abdelaziz, MD

CONTACT

1222373407; m.3abdelaziz@hotmail.com

moustafa Abdelaziz

CONTACT

1222373407; m.3abdelaziz@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anaesthesia and Surgical Intensive Care

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

EG (1)