TIPS Block vs Dual Subsartorial Block

Anesthesia, Local Clinical Trial

Official title:

TIPS Block vs Dual Subsartorial Block for Total Knee Arthrolplasty: Double Blinded Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096584
• Other study ID #: 0306191
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2023
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Joint Diseases
• Knee Arthropathy

Intervention

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
• 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.
• 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.
• 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.
• Suprasartorial plane block
Patients will receive a third injection of 10 ml of 0.25 % bupivacaine superficial to the sartorius under the facia lata

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & 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.0b — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total postoperative morphine requirements		1st 24 hours after surgery
Secondary	Postoperative functional outcome	Timed Up and Go (TUG) test. Score < 10s indicates normal mobility	1st 24 hours after surgery
Secondary	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