TIPS Block vs Dual Subsartorial Block

NCT06096584 | Unknown Phase 4

• 1 other identifier: 0306191
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Local; Knee Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative dynamic visual analogue scale score. It's a 0-10 score where 0 is no pain and 10 is the worst pain

  1st 24 hours after surgery

• Total postoperative morphine requirements

  1st 24 hours after surgery

• Postoperative functional outcome

  1st 24 hours after surgery

• Postoperative functional outcome

  1st 24 hours after surgery

Study Arms (2)

Group TIPS

EXPERIMENTAL

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; Procedure: Femoral triangle block; Procedure: Distal adductor canal block; Procedure: Suprasartorial plane block

Group Dual

ACTIVE COMPARATOR

patients will receive double level subsartorial canal block after induction of GA

Procedure: Dual sub sartorial block; Procedure: Femoral triangle block; Procedure: Distal adductor canal block

Interventions

Triple Injection Perisartorius block PROCEDURE

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

Group TIPS

Dual sub sartorial block PROCEDURE

Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone Patients will receive a combination of femoral triangle block and distal ACB.

Group Dual

Femoral triangle block PROCEDURE

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.

Group Dual; Group TIPS

Distal adductor canal block PROCEDURE

Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal.

Group Dual; Group TIPS

Suprasartorial plane block PROCEDURE

Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata

Group TIPS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

Related Publications (2)

• 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.

  PMID: 22886842 RESULT

• 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.

  PMID: 26129851 RESULT

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: SPONSOR

Model Details: Double blinded randomized controlled study

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 24, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after publication for one year
• Access Criteria: moustafa.abdelaziz@alexmed.edu.eg

Locations

EG (1)