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IRCT20240928063193N1 IRCT 2024-10-24 Karaj University of Medical Sciences Evaluation of the effect of topical sodium bicarbonate injection on pain after inguinal hernia surgery Evaluation of the effect of topical sodium bicarbonate injection on pain after inguinal hernia surgery 2024-11-20 anticipated 100 Complete https://irct.ir/trial/79248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be used for sampling. The length of the block for each of the treatment groups is considered to be 4, which means that each block will include two people from the intervention group and two people from the comparison group. If we show the people of the intervention group with the letter A and the people of the comparison group with the letter B, in this case according to the formula n!/r!(n!_r!) We will have 6 combinations of four in the form of (AA,BB), (AB, BA), (BA, BA), (BA, BA), (BB, AA), and (AB, BA). Then random codes will be generated for each of these blocks. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, eligible people will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to the intervention and comparison groups will continue until the desired sample size is reached. This method solves the problem of imbalance that can occur in simple randomization. To ensure the blinding of patients and assessors, each of these blocks will be identified with a code. On the other hand, the injection of normal saline containing sodium bicarbonate (intervention) and normal saline without sodium bicarbonate (placebo) will be done in the same amounts and using the same syringes, Blinding description: The purpose of blinding, depending on its type, is not to inform the patients and the investigator about the outcome of assigning people to treatment groups. In such studies, patients should not know which group they belong to.This point is very important, especially when a type of subjective measurement such as pain (result of this study) is involved. Therefore, this study was designed as a double blind. In this way, the evaluator and the subject (patients) are not aware of the status of assigning people to the study groups. For the study subjects, the procedure is explained before random assignment and receives one of the two treatments randomly And the medicine used for people is not known in advance, On the other hand, the injection of normal saline containing sodium bicarbonate (intervention) and normal saline without sodium bicarbonate (placebo) will be done in the same amounts and using the same syringes to irrigate the surgical field. in such a way that it is not possible for the patient to distinguish them from each other, Therefore, the patient will be unaware of which group she is in. The evaluator and the patient will not be aware of the patients belonging to the treatment groups. The process of sampling and preparing the material for spraying (Irrigate) is done by another person. 3 Unilateral indirect inguinal hernia, without obstruction or gangrene, recurrent. Intervention 1: In the intervention group (50 patients), a 30-minute session will be held to explain the study's objectives and the intervention process to obtain informed consent. The duration for which the patient will be involved in the study will be from the consent session (upon admission) until 24 hours after the surgery. During the surgery, after sterilizing the incision site and making the classic incision and repairing the defect, an inguinal hernia will be fixed using the Lichtenstein method: (this is a type of tension-free repair where a synthetic mesh (11x6 Proline mesh from Asia Surgical Company) is used to reconstruct the floor, and the mesh is placed in front of the transversalis fascia.) After placing the mesh, before closing the fascia, the surgical site will be irrigated once with 5 milliliters of diluted sodium bicarbonate solution at 7.5% (1 ml of 7.5% sodium bicarbonate diluted with 4 ml of normal saline). The source for this solution is a 50-milliliter vial of 7.5% sodium bicarbonate (NaHCO3) from Samen Pharmaceutical Company and a 100-milliliter bag of 0.9% sodium chloride (NaCl) from the samen company. After the surgery, all study patients will receive standard pain management as follows:1) Intravenous acetaminophen 1 gram every 8 hours2) Intravenous morphine 5 milligrams every 12 hours. Intervention 2: Control group: In the control group (50 patients), a 30-minute session is held to explain the study's objectives and the intervention method to obtain consent. The duration of the patient’s participation in the study will be from the consent session (before hospitalization) until 24 hours after the surgical procedure. During the surgical operation, after sterilizing the incision site and making the classical incision, the inguinal hernia repair is performed using the Lichtenstein method: (a type of tension-free repair where synthetic tissue (11x6 polypropylene mesh made by Asia Surgical Company) is used to reconstruct the floor and is placed in front of the transversalis fascia.) After placing the mesh, before closing the fascia, the surgical site is irrigated with 5 milliliters of normal saline solution once. The source of the solution is a 100 milliliter vial of 0.9 percent sodium chloride (NaCl) from Samen Pharmaceutical Company. After the surgery, all study patients will receive standard pain management as follows:1) Intravenous acetaminophen 1 gram every 8 hours2) Intravenous morphine 5 milligrams every 12 hours. 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 There is no further information
public Ali Rahmati
No. 45, Vakili Ave., East 16metri Ave., Chahar Bagh Square., South Janat Abad Blvd
Tehran Iran (Islamic Republic of) 1473875415 +98 21 4613 0915 alirahmatimd76@gmail.com Karaj University of Medical Sciences scientific Ali Rahmati
No. 45, Vakili Ave., East 16metri Ave., Chahar Bagh Square., South Janat Abad Blvd
Tehran Iran (Islamic Republic of) 1473875415 +98 21 4613 0915 alirahmatimd76@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) indirect inguinal hernia informed consent of patient not recurrence inguinal hernia 18 years 60 years Both psychopathy Drug addiction Chronic use of Analgesics Sensory and motor disorders Complications of strangulation and gangrene loss of consciousness Patients with acute problems and needing emergency surgeries recurrent inguinal hernia K40.91 Unilateral inguinal hernia, without obstruction or gangrene, recurrent Treatment - Drugs Placebo In the intervention group (50 patients), a 30-minute session will be held to explain the study's objectives and the intervention process to obtain informed consent. The duration for which the patient will be involved in the study will be from the consent session (upon admission) until 24 hours after the surgery. During the surgery, after sterilizing the incision site and making the classic incision and repairing the defect, an inguinal hernia will be fixed using the Lichtenstein method: (this is a type of tension-free repair where a synthetic mesh (11x6 Proline mesh from Asia Surgical Company) is used to reconstruct the floor, and the mesh is placed in front of the transversalis fascia.) After placing the mesh, before closing the fascia, the surgical site will be irrigated once with 5 milliliters of diluted sodium bicarbonate solution at 7.5% (1 ml of 7.5% sodium bicarbonate diluted with 4 ml of normal saline). The source for this solution is a 50-milliliter vial of 7.5% sodium bicarbonate (NaHCO3) from Samen Pharmaceutical Company and a 100-milliliter bag of 0.9% sodium chloride (NaCl) from the samen company. After the surgery, all study patients will receive standard pain management as follows:1) Intravenous acetaminophen 1 gram every 8 hours2) Intravenous morphine 5 milligrams every 12 hours Control group: In the control group (50 patients), a 30-minute session is held to explain the study's objectives and the intervention method to obtain consent. The duration of the patient’s participation in the study will be from the consent session (before hospitalization) until 24 hours after the surgical procedure. During the surgical operation, after sterilizing the incision site and making the classical incision, the inguinal hernia repair is performed using the Lichtenstein method: (a type of tension-free repair where synthetic tissue (11x6 polypropylene mesh made by Asia Surgical Company) is used to reconstruct the floor and is placed in front of the transversalis fascia.) After placing the mesh, before closing the fascia, the surgical site is irrigated with 5 milliliters of normal saline solution once. The source of the solution is a 100 milliliter vial of 0.9 percent sodium chloride (NaCl) from Samen Pharmaceutical Company. After the surgery, all study patients will receive standard pain management as follows:1) Intravenous acetaminophen 1 gram every 8 hours2) Intravenous morphine 5 milligrams every 12 hours The patient's pain score is based on Visual Analogue Scale (VAS). Timepoint: 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Karaj University of Medical Sciences Approved 2024-09-28 Ethics committee of Alborz University of Medical Sciences Deputy of Research and Technology .,saffarian Ave., 45 Metri of Golshahr ., Karaj Karaj Alborz Iran (Islamic Republic of)