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IRCT20220212054002N2 IRCT 2023-01-25 Mansoura university hospital Retrolaminar block in unilateral inguinal hernioraphy RLB The efficacy of the ultrasound-guided retrolaminar block versus the classic paravertebral block in patients undergoing unilateral inguinal hernioraphy: a randomized controlled study 2023-01-30 anticipated 50 Complete https://irct.ir/trial/68066 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Enrolled patients will randomly allocated to group (RLB) and group (PVB) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anesthesia by physician who will not involved in the study . The patients will be allocated to either group “RLB”, who receive retrolaminar block , or group “PVBB” who receive paravertebral block , with general anesthesia, Blinding description: Anesthesiologist who will perform the block will not be blinded to group assignment. However, anesthesiologist responsible of the patient and health care providers who collected the data will be blinded to group allocation. 2-3 Post operative pain control in unilateral inguinal hernia repair. Intervention 1: Control group:(BVB) patient will include the other 25 cases who will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral paravertebral space at level of T12. Intervention 2: Intervention group: (RLB) patient will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral retrolaminar space between the lamina of T12 and the paraspinal muscles. Yes - There is a plan to make this available What will be shared: IPD primary outcome measure only When: 6 month after published To whom: Academic institutions or businesses Conditions: Comparison Where to obtain: Email addresses zenatddd@gmail.com How to obtain: Request by Email Comments:
public Zenat Eldadamony Mohamed
Algomhouria street
Mansoura Egypt 35511 +20 100 726 8584 zenatddd@gmail.com Mansoura university hospital scientific Zenat Eldadamony Mohamed
Algomhouria street
Mansoura Egypt 35511 +20 100 726 8584 zenatddd@gmail.com Mansoura university hospital Egypt Age between 20 and 60 years and prepared for elective unilateral inguinal hernioraphy. American Society of anesthesiologists (ASA) I or II. 20 years 60 years Male Patients refusal ASA > II. Patients refusal h aving contraindications for the study medications. Infections at block site. History of substance abuse. Mental dysfunction. Metabolic disease Using anticoagulants. K40 Inguinal hernia Treatment - Other Treatment - Other Control group:(BVB) patient will include the other 25 cases who will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral paravertebral space at level of T12 Intervention group: (RLB) patient will receive 20 ml of bupivacaine 0.25%, will be injected ultra-sound guided into the ipsilateral retrolaminar space between the lamina of T12 and the paraspinal muscles Number of patients who needed rescue analgesia (morphine) in post operative. Timepoint: 24 hour post operative period. Method of measurement: Visual Analogue Scale to measure pain. Mean blood pressure ,and Heart rate. Timepoint: Basal(0), At skin incision, During sac traction, and At end of surgery. Method of measurement: Sphygmomonometer. Post-operative pain. Timepoint: Immediate post-operative (0) and At 2, 4,6,8,12,24 h post-operative. Method of measurement: Visual Analogue Scale. Mansoura university hospital Approved 2023-01-02 Institutional Research Board Algomhouria street Mansoura Mansoura Egypt