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IRCT20200513047418N1 IRCT 2020-06-02 Yazd University of Medical Sciences Evaluation of the effect of ketamine and bupivacaine combination on shoulder pain after gallbladder surgery by laparoscopy Investigate the Effect of Interaperitoneal ketamin plus bupivacaine administration for pain relief laparascopic cholecystectomy and comparison with bupivacaine alon 2019-07-01 anticipated 90 Complete https://irct.ir/trial/48136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: no have, Randomization description: For simple randomization, numbers 1-30 were considered for group one intervention, numbers 31-60 for group tow intervention, and numbers 61-90 for group three intervention were considered. Using computer software, sequences of random numbers were creat in the numerical range 1-90. The numbers were recorded and assigned to one of the three groups based on the numerical range defined by each group. hen a card was prepared according to the number of samples and on them was written one of the numbers 1,2,3 that represented the type of group. Based on the created sequence, the card for each group was placed in similar envelopes and arranged in a box. In order to maintain a random sequence, numbering was performed on the outer surface of the envelopes, respectively. fter obtaining the patient's consent, one of the letters was opened and the patient's group was identified based on the card number. The random allocation was hidden by the envelope, Blinding description: An evaluator of study variables is the ward nurse who was unaware of the type of study and the subject of the study as well as the type of medication the patients received. Patients were unaware of their group and the medication they should receive And they were told that they were in one of the study groups. 3 Shoulder pain after laparoscopic surgery. Intervention 1: Intervention group: In this group, 10 cc of bupivacaine 0.5% is combined with 0.5 mg / kg of ketamine, and with a normal saline of 0.9%, the volume of the drug reaches 20 cc.The compound is injected into the peritoneum at the end of the surgery and after the gallbladder is removed. Intervention 2: Intervention group: In the second group, 10 cc of bupivacaine 0.5% with 10 cc of normal saline 0.9%, reaches a volume of 20 cc, and at the end of surgery and after removing the gallbladder, is injected into the peritoneum at the site of surgery. Intervention 3: Control group: 20 cc of normal saline is injected into the peritoneum as a placebo at the end of surgery and after removal of the gallbladder. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have not been identified. When: Start the course after publishing the results To whom: For researchers at academic and scientific institutions Conditions: The applicant's academic resume is required. Where to obtain: They can contact us by email: p.ziaiei@ssu.ac.ir How to obtain: The person receives the data by sending his / her scientific resume for a maximum of 3 months. Comments:
public Parvin Ziaiei
NO. 30 , Saadi Lane., Saadi Cross., Eastern Hasht Behesht Ave.,
Esfahan Iran (Islamic Republic of) 81579-55981 +98 31 3265 3741 p.ziaiei@ssu.ac.ir Yazd University of Medical Sciences scientific Dr. Saeed Kargar
Shahid Sadoughi Hospital., Ibn Sina St., Shahid Ghandi Blvd
Yazd Iran (Islamic Republic of) 8916886938 +98 35 3822 4000 saeedkargar@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) elective laparascopic cholecystectomy age 18 -65 year weight 55-100 kg The duration of surgery is less than two hours. No neurovascular disease, coagulation disorders, cardiovascular disease • No history of ketamine and bupivacaine allergy No history of abdominal surgery 18 years 65 years Both use of alcohol, painkillers and anti-inflammatory and non-steroidal anti-inflammatory drugs Having chronic pain unrelated to gallbladder disease Dissatisfaction of the patient to continue participating in this study he need for laparotomy during laparoscopy having acute cholecystitis People who could not understand VAS. R52 Pain, unspecified Prevention Prevention Placebo Intervention group: In this group, 10 cc of bupivacaine 0.5% is combined with 0.5 mg / kg of ketamine, and with a normal saline of 0.9%, the volume of the drug reaches 20 cc.The compound is injected into the peritoneum at the end of the surgery and after the gallbladder is removed. Intervention group: In the second group, 10 cc of bupivacaine 0.5% with 10 cc of normal saline 0.9%, reaches a volume of 20 cc, and at the end of surgery and after removing the gallbladder, is injected into the peritoneum at the site of surgery. Control group: 20 cc of normal saline is injected into the peritoneum as a placebo at the end of surgery and after removal of the gallbladder. The severity of shoulder pain after laparoscopic surgery on (Visual Analogue Scale). Timepoint: Two, four, six, eight hours after surgery. Method of measurement: Visual Analogue Scale(VAS). Hypotension, pressure drop above 20% initial value. Timepoint: An hour before surgery and two, four, six, eight hours after laparoscopic cholecystectomy. Method of measurement: By a sphygmomanometer. Number of heartbeats. Timepoint: An hour before surgery and in 2-4-6-8 hours after surgery. Method of measurement: By counting the number of pulses per minute that is recorded in the checklist. Dosage of analgesics. Timepoint: 8 hours after surgery. Method of measurement: Using a syringe, it is registered in the checklist in milligrams. The first time analgesics are needed. Timepoint: 8 hours after surgery. Method of measurement: It is registered in the checklist and based on the minute. Nausea and vomiting. Timepoint: 2-4-6-8 hours after surgery. Method of measurement: View and ask .By options has and does not have in the checklist. Yazd University of Medical Sciences Approved 2019-07-29 Ethics Committee of the Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd Alam Square,. Shahid Sadoughi University of Medical Sciences Campus,. Yazd - Faculty of Health. Yazd Yazd Iran (Islamic Republic of)