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IRCT20200314046763N1 IRCT 2020-05-11 Shahid Beheshti University of Medical Sciences Evaluation of the effect of pre-capsular nerve group block on opoid intra-operative consumption and analgesic effects after hip fracture surgery PENG The comparison of pericapsular nerve group block (PENG block) with fascia iliaca block on opioid intra-operative consumption and post-operative analgesic effects in extra-capsular and intra-capsular hip fracture 2020-03-20 anticipated 36 Complete https://irct.ir/trial/46612 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Accidentalization was performed using block randomization method with 9 blocks and 2, 4, 6, 8 in blocks using blockrand package in R software, Blinding description: In the first step, the first and second intervention groups will be placed in the envelope. The study is double blind in that the patient will not be aware of the type of treatment, the evaluator will be different from the therapist, and the evaluator will be uninformed, but the therapist will be aware of the treatment. The evaluator will examine the patients at the beginning of their visit and refer them to a therapist if they have the conditions to study, and the therapist will select the treatment envelope according to the random block method. In the next step, the evaluator will perform the evaluation without knowing the assigned method. 3 Pericapsular Nerve Group (PENG) block. Intervention 1: Intervention group: PENG nerve block in intraoperative drug use and postoperative analgesic effects in intra-capsular and extracapsular hip fracture groups.After sterilizing the site and performing a skin anesthesia, the curve linear, low-frequency (2-5 MHz) is taken transversely on the Anterior Inferior iliac Spine, by rotating 45 degrees counterclockwise. The femoral artery and pectinus muscle are seen. The nidel is like the nidel of the control group and is inserted from the lateral to the medial in an in-plane so that its tip is located in the fascial muscle between the posterior psoas tendon and the posterior Ramus pubis after aspiration. Negative 0.5% vacuum solution is injected at 3 ml / kg with aspiration every 5 cc. Intervention 2: Control group: Patients with Fascia Iliaca Neural Block: Patients who undergo vital signs and appropriate intravenous lineage after receiving transfer to the operating room and monitoring with normal saline intake of 5-5 cc / kg, will undergo the following Fascia Iliaca nerve block as follows: Sterilize the block site and perform a skin anesthesia with a 2 cc Needle syringe with 1% lidocaine injection, with the help of a high-frequency linear transducer (10-25 MHz ultrasound device (S-Nerve Sonosite)) that is placed horizontally in the inguinal area. In-plan and with needle (B Brain (22 G, 80 mm, Stimuplex Ultra 360 in the amount of 3 ml / kg and a maximum of 40 ml of Rupivacaine 0.5% (Multeni) with direct view between the fascia The iliac and iliopsoas muscles are injected. Yes - There is a plan to make this available What will be shared: All potential data can be shared after unidentifiable people When: Start of access period 6 months after printing results To whom: Researchers working in academic and scientific institutions Conditions: 1. Respecting the ethics and religion of the patients who participate in these studies. 2-To help improve the validity of the data produced. 3. Assist physicians in interpreting and minimizing disruption to clinical trials. 4. Prevent the recruitment of volunteers who are exposed to the dangers of high-risk trials. 5. Mass media information on the effects of trials that do not conform to the interests of pharmaceutical companies. Where to obtain: drhamidrezasamadpour@gmail 00989125395847 How to obtain: After logging into the system to provide results, three methods are envisaged in which the results can be accessed in different formats. Please click on "Search Output" to make the options visible in the menu. Comments:
public Hamidreza Samadpour
No. 21, 12 Metri Taleghaani Ave., Nasim Ave., Kamaali Sharghi Blvd., Poonak
Tehran Iran (Islamic Republic of) 1476985487 +98 21 4460 4203 hamidrezasamadpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hamidreza Samadpour
No. 21, 12 Metri Taleghaani Ave., Nasim Ave., Kamaali Sharghi Blvd., Poonak
Tehran Iran (Islamic Republic of) 1476985487 +98 21 4460 4203 hamidrezasamadpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with hip fractures Elective surgery Hemoglobin levels above 9 mg / dl Age 50 to 75 years ASA class I and II patients 50 years 75 years Both Other fractures or other lesions require surgery History of drug or psychotropic addiction Presence of psychiatric illnesses Existence of coagulation disorder Sensitivity to local anesthetics Nervous disorders in the nerves of the lower extremities Rehabilitation Rehabilitation Intervention group: PENG nerve block in intraoperative drug use and postoperative analgesic effects in intra-capsular and extracapsular hip fracture groups.After sterilizing the site and performing a skin anesthesia, the curve linear, low-frequency (2-5 MHz) is taken transversely on the Anterior Inferior iliac Spine, by rotating 45 degrees counterclockwise. The femoral artery and pectinus muscle are seen. The nidel is like the nidel of the control group and is inserted from the lateral to the medial in an in-plane so that its tip is located in the fascial muscle between the posterior psoas tendon and the posterior Ramus pubis after aspiration. Negative 0.5% vacuum solution is injected at 3 ml / kg with aspiration every 5 cc. Control group: Patients with Fascia Iliaca Neural Block: Patients who undergo vital signs and appropriate intravenous lineage after receiving transfer to the operating room and monitoring with normal saline intake of 5-5 cc / kg, will undergo the following Fascia Iliaca nerve block as follows: Sterilize the block site and perform a skin anesthesia with a 2 cc Needle syringe with 1% lidocaine injection, with the help of a high-frequency linear transducer (10-25 MHz ultrasound device (S-Nerve Sonosite)) that is placed horizontally in the inguinal area. In-plan and with needle (B Brain (22 G, 80 mm, Stimuplex Ultra 360 in the amount of 3 ml / kg and a maximum of 40 ml of Rupivacaine 0.5% (Multeni) with direct view between the fascia The iliac and iliopsoas muscles are injected. Pain. Timepoint: 6, 12 and 24 hours after surgery. Method of measurement: Visual Analog Scale(VAS). Opioid intra-operative consumption. Timepoint: At the beginning of the surgery and then every 15 minutes. Method of measurement: Numeric rating scale. Shahid Beheshti University of Medical Sciences Approved 2019-05-14 Iran national committee for Ethics in biomedical research Tehran - Qods Township (West) - 13th Floor Between South Flamak and Zarafshan, Iran Sime St. - Headquarters of Ministry of Health and Medical Education, Block A Tehran Tehran Iran (Islamic Republic of)