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IRCT20230809059091N2 IRCT 2023-08-16 CMH Rahim Yar Khan PENG VERSUS FIB COMPARISON OF THE NOVEL PENG (PERICAPSULAR NERVE GROUP) BLOCK VERSUS FASCIA ILIACA BLOCK (FIB) IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY 2023-08-09 anticipated 150 Complete https://irct.ir/trial/71923 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non-probability consecutive sampling by lottery method into the two interventional groups, Blinding description: Single blind with the patient unaware of the block type done. N/A Pain with total hip arthroplasty due to osteoarthritis. Intervention 1: Intervention group: Group F (Fascia iliac block group) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the facia iliac plane. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization. Intervention 2: Intervention group: Group P (pericapsular nerve group block) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the pericapsular space and blocking corresponding nerves. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization. Yes - There is a plan to make this available What will be shared: Output SPSS sheets and all excel data sets When: After approval of the manuscript by the journal To whom: Everyone open access Conditions: The study data including excel sheets and SPSS output files can be used after permission from the primary author who would receive the application for data use via email Where to obtain: The data will be uploaded on the Google drive of the primary author with the email (nabeel4allz@gmail.com) and will be available after a formal email request How to obtain: A formal email on the address given to the primary author of the article. Any queries asked by the author would be done through email and link to the data from google drive would be sent after author approval (usual time till approval is 7 days) Comments:
public Nabeel Butt
Chowk Bahadarpur
Rahim Yar Khan Pakistan 64200 +92 313 5969696 nabeel4allz@gmail.com Combined Military Hospital Rahim Yar Khan scientific Dr. Nabeel Tahir Butt
Chowk Bhadarpur
Rahim Yar Khan Pakistan 64200 +92 313 5969696 nabeel4allz@gmail.com Combined Military Hospital Rahim Yar Khan Pakistan Included all ASA-II (American society of Anaesthesiologists) male and female patients above the age of fifty years Requiring total hip arthroplasty (THA) due to advanced osteoarthritis of the hip joint. 50 years 75 years Both Excluded patients with major cardiac or respiratory debility, metastatic bone disease, allergy to drugs used for the block, bleeding diathesis, coagulation defects, patients with patchy or failed block after administration and patients not willing to be included in the study. Metastatic bone disease Allergy to the drugs used in the block (lignocaine) Bleeding diathesis and coagulation disorders Patients with patchy or failed block after administration Patients not willing to be included in the study M16 Osteoarthritis of hip Treatment - Other Treatment - Other Intervention group: Group F (Fascia iliac block group) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the facia iliac plane. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization Intervention group: Group P (pericapsular nerve group block) will receive the block pre-operatively in the operating room with the patient unaware of the block performed by a consultant anesthetist with at least 5 years of experience under ultrasound guidance administering 20 ml of local anesthetic (2% ligonicaine) in the pericapsular space and blocking corresponding nerves. After surgery median pain scores assessment would be done by standard visual analog scale at 3,6,12 and 24 hour duration along with time to patient mobilization Mean time for first dose of rescue analgesia and mean time to patient mobilization. Timepoint: Within 12 hours post-surgery. Method of measurement: Standard Visual Analog scale for pain assessment. None Approved 2023-08-01 Ethical review board Combined Military Hospital Rahim Yar khan Chowk Bahadarpur Rahim Yar Khan Punjab Pakistan