Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair

Analgesic Efficacy of Genicular Nerve Block Versus Local Anaesthetic Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK Block ) in Patients Undergoing Anterior Cruciate Ligament (ACL) Repair by Knee Arthroscopy . A Randomized Controlled Prospective Study .

One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Genicular nerve block

Detailed Description

The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana AbdElsayed Mansour; Phone Number: MD 01222960009; Email: mrmrsyk4@gmail.com

Study Locations

• Egypt
  • Benisuef, Egypt
    • Recruiting
    • Benisuef university hospital
    • Contact: Mariana AbdElsayed Mansour, MD; Phone Number: 01222960009; Email: mrmrsyk4@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) <40 kg/m2

Exclusion Criteria:

• -Patients were excluded if they refused consent.
• Patients who are Not cooperative.
• BMI >40 kg/m2.
• Allergy to local anesthetics.
• Patients with anticoagulation or bleeding problems.
• Previous nerve dysfunction.
• Physical status ASA class IV.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; did not receive any block just spinal anathesia.
Active Comparator: Genicular nerve block; patients who receive Genicular nerve block with spinal anathesia .	Procedure: Genicular nerve block; patients who receive Genicular nerve block with spinal anathesia .
Active Comparator: IPACK block; patients who receive IPACK block with spinal anathesia.	Procedure: Genicular nerve block; patients who receive Genicular nerve block with spinal anathesia .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Measuring pain intensity regarding mean visual analogue score (VAS score ) ranging from 0 (no pain) to 10 (the worst imaginable pain.	48 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory score	Ambulatory score from ( 0 to 2) (score of 0) is assigned if the activity cannot be performed despite substantial help (score of 1 )is assigned if the activity is performed using personal physical support. (score of 2) is assigned if the activity is performed independently.	Within 48 hour
Time of first rescue analgesia	the time to ask for the first post operative analgesia	within 24 hour
Total opioid consumption post operative	Total opioid consumption post operative	Within 24 hour
Incidence of occurrence of systemic toxicity	( hypotension ,arrthymias, bradycardia, cardiac arrest, oral numbness and convulsions	Within 24 hour
The length of hospital stay .	The length of hospital stay .	within one week

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FMBSUREC/02012024/Kamal

Drug and device information, study documents

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