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IRCT20220409054465N2 IRCT 2024-02-04 Tehran University of Medical Sciences Comparision of the effect of Subdiaphragmatic Saline and sodium- bicharbonate Irrigation for Reducing Postoperative Shoulder Pain after Laparoscopic hysterctomy Surgeries Comparision of the effect of Subdiaphragmatic Saline and sodium- bicharbonate Irrigation for Reducing Postoperative Shoulder Pain after Laparoscopic hysterctomy Surgeries 2024-02-04 anticipated 90 Complete https://irct.ir/trial/73480 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients undergo laparoscopic hysterectomy by a team of surgeons. And the intervention will be done based on the block randomization list by the operating room technician, and after random assignment, the patients will be divided into 3 groups. Randomization in this study is done in the form of block randomization. Randomly permuted blocks (block size of 3) will be generated using the website www.sealedenvelope.com and will be written on the drug envelopes. After receiving the consent form and after confirming the eligibility of the patient, the random code will be randomized based on the randomization sheet by the main researcher and based on a predetermined randomization plan in the ratio of 1:1:1 to receive drug or serum or control. and receive their corresponding intervention box. This number was considered as the participant's randomization code and will be identified with this number until the end of the study. Randomization using closed envelopes based on the type of medicine is given to the operating room technician and then the patients are followed up, Blinding description: After obtaining informed consent from the patient to participate in the study, the patient will not know the type of intervention he received. In order to hide the random allocation process, the sequence of treatments will be written on the cards in order, then the cards will be placed in sealed envelopes. A 10-digit random code will be written on each envelope without any order or frame, which is the identification number of the relevant patient, and only one of the executive agents of the project, who will not be involved in the evaluation, analysis and interpretation of the results, will be aware of the relevant code. When another doctor (clinical caregiver) declares the eligibility of a patient, the nurse provides the envelope to the doctor and the desired surgical intervention will be performed based on the type mentioned in the envelope. And the results of the study will be checked by a outcome assessor who is unaware of the type of intervention. Due to the anesthesia during the surgery, the patients will not know the type of intervention. The statistics analyzer and the researcher will not be aware of the type of medicine used. N/A Reduction of shoulder pain after laparoscopic surgery. Intervention 1: Intervention group 1: In the first group (saline group): during normal surgery, 500 cc of saline is sprayed under the right hemodiaphragm before removing carbon dioxide. Intervention 2: Intervention group2: In the second group (sodium bicarbonate group), 50 cc of 7.9% sodium bicarbonate (factory and country of manufacture) in 500 cc of 0.9% normal saline will be sprayed at the end of the surgery in the same way as the saline group. Intervention 3: In the control group (group 3), no intervention will be performed. At the end of the procedure, the patient is supine and the gas is released slowly. 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 Its release schedule is not yet known
public Lida Garrosi
Tehranpars street , Baghdarnia ave, Arash hospital
Tehran Iran (Islamic Republic of) 1653915981 9922 7771 21 98+ Lgarrosi@zums.ac.ir Tehran University of Medical Sciences scientific Lida garrosi
Tehranpars, Rashid BLV, Arash Hospital
Tehran Iran (Islamic Republic of) 1653915981 9922 7771 21 98+ lgarrosi@zums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Elective laparoscopic hysterectomy surgery Age 20 to 60 years ASA (anesthesia class) 1 and 2 No allergy to sodium bicarbonate Absence of liver and kidney dysfunction Absence of heart disease Absence of previous shoulder pain or myofascial pain Absence of cognitive impairment 20 years 60 years Female Unwillingness to participate in the study Cancer of the uterus and ovaries With severe intra-abdominal adhesions History of underlying diseases (stroke, cerebral thrombosis, chronic hypertension, liver and kidney diseases) Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group 1: In the first group (saline group): during normal surgery, 500 cc of saline is sprayed under the right hemodiaphragm before removing carbon dioxide. Intervention group2: In the second group (sodium bicarbonate group), 50 cc of 7.9% sodium bicarbonate (factory and country of manufacture) in 500 cc of 0.9% normal saline will be sprayed at the end of the surgery in the same way as the saline group In the control group (group 3), no intervention will be performed. At the end of the procedure, the patient is supine and the gas is released slowly. Shoulder pain. Timepoint: 12,24,48 hours after surgery. Method of measurement: VAS questionnaire. Extra sedative. Timepoint: 12,24,48 hours after surgery. Method of measurement: number of requested sedative. Tehran University of Medical Sciences Approved 2023-10-30 Tehran university of Medical science Qods street, Keshavarz boulevard Tehran Tehran Iran (Islamic Republic of)