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IRCT20120814010599N25 IRCT 2020-01-24 Iran University of Medical Sciences Effect of the ultrasound-guided erector spinae plane block on the degree of post laparoscopic cholecystectomy pain Investigation of the Ultrasound-guided erector spinae plane block effect on the degree of the post laparoscopic cholecystectomy pain 2020-02-01 anticipated 62 Complete https://irct.ir/trial/37231 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 15 blocks and also one block of 2 patients (Totally 62 patients). Then, within each block, subjects will be randomly assigned to intervention or control group . Random assignment will be done using a random number table, Blinding description: In this study, a single-blind technique in which the person recording the information has no idea regarding the control or case group is used. N/A Laparoscopic cholecystectomy. Intervention 1: Intervention group:After the operation, upon arrival the patient to the recovery unit and monitoring, the patient is positioned left laterally, the right side is prep and drep, the probe of sonography is located longitudinally at the level of T7 (lower border of scapula) and after determination the lower and upper transverse processes, the needle is inserted in plane toward the erector spinae plane muscle. 20 cc Ropivacaine 0/2% is injected into the fascia of erector spinae plane muscle (behind the transverse process). A PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient in both groups. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl). Intervention 2: Control group: After the operation, upon arrival the patient to the recovery unit and monitoring, a PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not clear yet.
public Dr. Poupak Rahimzadeh
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
Tehran Azerbaijan 1445613131 02164352493 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences scientific Dr. Poupak Rahimzadeh
Rasoul Akram Hospital, Mansouri St., Niyayesh Ave., Satarkhan St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2493 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) patients with ASA =< 2 patients with the age of 20-65 years old under laparoscopic cholecystectomy 20 years 65 years Both Emergent patients History of allergy to Ropivacain Patients received analgesic during the last 24 hours Patients with BMI > 35 Patients with liver disease, renal disease and coagulopathy or a history of it Changing the plan of the surgery from the laparoscopy to the open cholecystectomy or occurrence of any problem during the operation K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Other Treatment - Drugs Intervention group:After the operation, upon arrival the patient to the recovery unit and monitoring, the patient is positioned left laterally, the right side is prep and drep, the probe of sonography is located longitudinally at the level of T7 (lower border of scapula) and after determination the lower and upper transverse processes, the needle is inserted in plane toward the erector spinae plane muscle. 20 cc Ropivacaine 0/2% is injected into the fascia of erector spinae plane muscle (behind the transverse process). A PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient in both groups. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl). Control group: After the operation, upon arrival the patient to the recovery unit and monitoring, a PCIA pomp containing 12 cc fentanyl in 100 cc (6microgram pro 1 cc) is connected to patient. The flow of the pomp will be zero and the use of the bolus bottom is instructed to the patient. (bolus = 2 cc) the patient is delivered 12-mcg of fentanyl each time the pump is pressed (in one hour at most 48-mcg fentanyl). The degree of the pain based on the Numerical Rating Scale criterion. Timepoint: 0 means at the time of arrival to the recovery, 20 minutes after the implementation of the block, 2, 4, 6, 12, and 24 hours after the surgery. Method of measurement: The degree of the pain based on the Numerical Rating Scale criterion. The amount of the opioid used during the first 24 hours after the surgery in milligrams. Timepoint: 0 means at the time of arrival to the recovery, 20 minutes after the implementation of the block, 2, 4, 6, 12, and 24 hours after the surgery. Method of measurement: Based on the amount of the used opioid reported by the person recording the information in the questionnaire in milligrams. Iran University of Medical Sciences Approved 2018-12-23 Ethics committee of Iran University of Medical Sciences Vice-chancellor for research and technology of Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)