The Analgesic Efficacy of Ultrasound Guided Adductor Canal Block Versus 4 in 1 Block in Patients Undergoing Knee Surgeries: A Comparative Randomized Double Blinded Study . (No acronym)

Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019)

Study Overview

• Status: Active, not recruiting
• Conditions: Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block )
• Intervention / Treatment: Procedure: adductor canal block; Procedure: 4 in one block

Detailed Description

Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019). Regarding the functional anatomy of the nerve supply to knee joint: The knee is innervated by genicular branches from the nerve to vastus medialis, saphenous nerve, sciatic nerve and the posterior division of obturator nerve. The skin around the knee is supplied by the cutaneous branches from the femoral nerve and the saphenous nerve (Ritesh Roy, Gaurav Agarwal, et al, 2018). The widespread use of ultrasound to advance peripheral nerve block techniques over the past decade has led to enormous growth in the utilization and efficiency of regional anesthesia (Cozowicz, Crispiana & Poeran, et al, 2015). The adductor canal block (ACB) is an interfascial plane block performed in the middle third of the medial side of the thigh. The adductor canal bounded anteriorly by the sartorius muscle, posteriorly and medially by the adductor longus and magnus muscles, and laterally by the vastus medialis muscle. It contains the femoral vein and artery, the saphenous nerve and the nerve to the vastus medialis, both are sensory branches of the femoral nerve. In some individuals, the obturator sensory branch (also a femoral nerve branch) can be affected by local anesthetic infiltration into this area. It can be noted that this block affect sensory branches and avoid blocking the majority of motor branches. The block is most commonly performed using ultrasound guidance (Thiayagarajan MK, Kumar SV,et al 2019). Ultrasound guided 4-in-1 block technique: a new single injection technique described by Roy R, Agarwal G, et al, 2018 for the combined 4 nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) with a single injection point is located at the adductor hiatus where descending genicular artery branches from superficial femoral artery. Bupivacaine is a long-acting amide local anesthetic (max. dose 2.5 mg/kg). Symptoms contributed to local anesthetic toxicity include tinnitus, perioral tingling, visual disturbances and dizziness (Shafiei FT, McAllister RK, Lopez J, 2022)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud H Bahr; Phone Number: Beni-Suef 00201004413095; Email: mahmoud.mohamed1@med.bsu.edu.eg
• Study Contact Backup: Name: Shereen G Saad; Phone Number: Beni-suef 00201155563450; Email: Sherysaad33@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 62511
    • Faculty of medicine.Beni-suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Both sexes.
• ASA grade 1 and 2.
• Age group between 20-60 years.
• Patients who will undergo knee surgeries under neuroaxial anesthesia.

Exclusion criteria:

• Patient refusal.
• Patients who are allergic to any of study drugs.
• Absolute contraindication causes to spinal anesthesia due to coagulopathy, severe aortic/mitral stenosis, or active infection at site of injection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: adductor canal block; adductor canal block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle	Procedure: adductor canal block; patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block).; Procedure: 4 in one block; patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block).
Active Comparator: 4 in one block; 4 in one block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery .	Procedure: adductor canal block; patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block).; Procedure: 4 in one block; patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score: resting and dynamic .	Postoperative pain score: resting and dynamic pain using NRS at postoperative 6 hours.Numerical rating scales (NRSs) are the simplest and most commonly used scales. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around (written version) the number that best describes the pain dimension, usually intensity.	6 hours Postoperative
Postoperative pain score: resting and dynamic	Postoperative pain score: resting and dynamic pain using NRS at postoperative 12 hours.	12 hours post operative
Postoperative pain score: resting and dynamic	Postoperative pain score: resting and dynamic pain using NRS at postoperative 18 hours.	18 hours post operative
Postoperative pain score: resting and dynamic	Postoperative pain score: resting and dynamic pain using NRS at postoperative 24 hours.	24 hours post operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of blood pressure .	Change of blood pressure (systolic, diastolic, mean pressure): Evaluation of the blood pressure before and 30min after applying the assigned block before receiving anesthesia. Then, we will calculate the change of blood pressure at the two time points.	Intraoperative
Change of heart rate .	Change of heart rate: Evaluation of the heart rate before and 30 min after applying the assigned block before receiving anesthesia. Then, we will calculate the change of heart rate at the two time-points	Intraoperative
Postoperative opioid requirements .	First time for opioid rescue and total dose in the frist 24 hours.	24 hours post operative

Collaborators and Investigators

• Sponsor: Mahmoud Hussein Bahr

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound guided adductor canal block .; 4 in 1 block .; knee surgeries .
• Other Study ID Numbers: FMBSUREC/12022023/saad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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