TIPS Block vs Dual Subsartorial Block

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Local; Knee Arthropathy
• Intervention / Treatment: Procedure: Triple Injection Perisartorius block; Procedure: Femoral triangle block; Procedure: Distal adductor canal block; Procedure: Suprasartorial plane block; Procedure: Dual sub sartorial block

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).

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21651
    • Alexandria Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: Triple Injection Perisartorius block; 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; Procedure: Femoral triangle block; 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.; Procedure: Distal adductor canal block; Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal.; Procedure: Suprasartorial plane block; Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata
Active Comparator: Group Dual; patients will receive double level subsartorial canal block after induction of GA	Procedure: Femoral triangle block; 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.; Procedure: Distal adductor canal block; Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal.; Procedure: Dual sub sartorial block; Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone Patients will receive a combination of femoral triangle block and distal ACB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1st 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1st 24 hours after surgery
Total postoperative morphine requirements		1st 24 hours after surgery
Postoperative functional outcome	Timed Up and Go (TUG) test. Score < 10s indicates normal mobility	1st 24 hours after surgery
Postoperative functional outcome	30-second Chair Stand Test (30s-CST). The number of times the patient can stand and sit in 30 seconds	1st 24 hours after surgery

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 0306191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request
• IPD Sharing Time Frame: Data will be available after publication for one year
• IPD Sharing Access Criteria: moustafa.abdelaziz@alexmed.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No