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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06404658
Other study ID # FMBSUREC/02012024/Kamal
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2024
Est. completion date October 30, 2024

Study information

Verified date May 2024
Source Beni-Suef University
Contact Mariana AbdElsayed Mansour
Phone 01222960009
Email mrmrsyk4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Genicular nerve block
patients who receive Genicular nerve block with spinal anathesia .

Locations

Country Name City State
Egypt Benisuef University Hospital Benisuef

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Time of first rescue analgesia the time to ask for the first post operative analgesia within 24 hour
Secondary Total opioid consumption post operative Total opioid consumption post operative Within 24 hour
Secondary Incidence of occurrence of systemic toxicity ( hypotension ,arrthymias, bradycardia, cardiac arrest, oral numbness and convulsions Within 24 hour
Secondary The length of hospital stay . The length of hospital stay . within one week
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