TIPS Block vs Dual Subsartorial Block

Sponsor
Alexandria University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096584
Collaborator
(none)
88
1
2
7
12.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Triple Injection Perisartorius block
  • Procedure: Dual sub sartorial block
  • Procedure: Femoral triangle block
  • Procedure: Distal adductor canal block
  • Procedure: Suprasartorial plane block
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double blinded randomized controlled studyDouble blinded randomized controlled study
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double blinded
Primary Purpose:
Treatment
Official Title:
TIPS Block vs Dual Subsartorial Block for Total Knee Arthrolplasty: Double Blinded Randomized Controlled Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative resting 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]

    Resting visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

Secondary Outcome Measures

  1. 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]

    Dynamic visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

  2. Total postoperative morphine requirements [1st 24 hours after surgery]

  3. Postoperative functional outcome [1st 24 hours after surgery]

    Timed Up and Go (TUG) test. Score < 10s indicates normal mobility

  4. Postoperative functional outcome [1st 24 hours after surgery]

    30-second Chair Stand Test (30s-CST). The number of times the patient can stand and sit in 30 seconds

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Faculty of Medicine Alexandria Egypt 21651

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT06096584
Other Study ID Numbers:
  • 0306191
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023