TIPS Block vs Dual Subsartorial Block

NCT ID: NCT06096584

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-07-31

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

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).

Conditions

Anesthesia, Local; Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study 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 Type: EXPERIMENTAL

Triple Injection Perisartorius block

Intervention Type: 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

Femoral triangle block

Intervention Type: 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.

Distal adductor canal block

Intervention Type: 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.

Suprasartorial plane block

Intervention Type: PROCEDURE

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

Group Dual

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

Group Type: ACTIVE_COMPARATOR

Dual sub sartorial block

Intervention Type: PROCEDURE

Drug: Bupivacaine 0.25 % mixed with 2 mg dexamethasone

Patients will receive a combination of femoral triangle block and distal ACB.

Femoral triangle block

Intervention Type: 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.

Distal adductor canal block

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexandria Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 22886842 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26129851 (View on PubMed)

Other Identifiers

0306191

Identifier Type: -

Identifier Source: org_study_id