]>
IRCT20190901044665N1 IRCT 2019-10-30 Ardabil University of Medical Sciences Comparison Between Sublingual Buprenorphine and Fentanyl Intravenous Pump for Postoprative Pain Relief After Open Cholecystectomy Surgery. Comparison Between Sublingual Buprenorphine and Fentanyl Intravenous Pump for Postoprative Pain Relief After Open Cholecystectomy Surgery. 2019-06-22 anticipated 80 Complete https://irct.ir/trial/41901 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: After patients were allowed to enter the study 80 patients were selected using simple sampling and the selected patients will be divided into two groups by random block design with 4 blocks. In this case all possible modes were considered to accommodate the letters AABB which is 6 modes. These 6cases were embedded in 6 papers and the papers were embedded in a black bag. Then we will make 20 paper bags every time. We draw a piece of paper write down the letters in it and we will add the next letter in the next drawing followed by the previous note we will have 80 letters in the end and at the time of sampling each person will receive a special letter in order of entry into the sample and so the people feel into one group , Blinding description: The first group of 40 patients receiving Sublingual Buprenorphine Tablet and intravenous placebo Pump The second group will consist of 40 patients receiving Sublingual placebo Tablet and intravenous Fentanyl Pump. All Patients will be anesthetized by one-way treatment Protocol. Given that the study is randomly blocked,Buprenorphine and Placebo Buprenorphine and Fntanyl Pump and placebo pump separately and in two packs (Containing one pump and one Tablet) with specific codes B and A (Pack A containing Sublingual Buprenorphine and Placebo Pumps and and Pack B containing Placebo Tablets and Fentanyl Pumps) and The drug injector (Anesthetic Technician) has no information about the contents of the pack Select Pack A or B based on the Patient group. already specified are provided and every morning before the operation the number of Surgeries will be eliminated the same day.Start prescribing housing content envelopes after complete Cholecystectomy And it will be done in recovery. Patients will not be informed about the type of drug they receive. 3 Comparison between Sublingual Buprenorphine and Fentanyl Intravenous Pump for postoperative pain relief after open Cholecystectomy Surgery. Intervention 1: In the intervention group, Sublingual Buprenorphine Tablet administered 0.4 mg in 6, 12 and 18 hours recovey and Placebo Pump 50 cc normal saline in recovery and continued for 24 hours, if pain is not controlled, PCA is injected every 15 minutes. Intervention 2: Control group:In the control group, Placebo Tablets were administered at 6,12 and 18 h,50 cc intravenous Fentanyl Pump (40 cc Fentanyl and 10 cc normal saline) embedded and half a cc (20 micrograms) of stat is injected and if the pain is not controlled, PCA is given by the patient. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to Ethical Problems and Patient safety, The publish of IPD not applicable.
public Ahmad Ghazi
Imam Reza Hospital , Basij Square
Ardabil Iran (Islamic Republic of) 5618985991 009844838649 dr.ghaziahmad@gmail.com Ardabil University of Medical Sciences scientific Ahmad Ghazi
Imam Reza Hospital, Basij square
Ardabil Iran (Islamic Republic of) 5618985991 +98 914 151 5271 dr.ghaziahmad@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients undergoing open cholecystectomy Patients ASA 1and2 Patients who have no further surgery Age range 20 to 50 years 20 years 50 years Both History of opium use Nervous drug history Active asthma ASA3 Other concurrent surgery Surgery lasted Complicated surgery Treatment - Drugs Placebo In the intervention group, Sublingual Buprenorphine Tablet administered 0.4 mg in 6, 12 and 18 hours recovey and Placebo Pump 50 cc normal saline in recovery and continued for 24 hours, if pain is not controlled, PCA is injected every 15 minutes. Control group:In the control group, Placebo Tablets were administered at 6,12 and 18 h,50 cc intravenous Fentanyl Pump (40 cc Fentanyl and 10 cc normal saline) embedded and half a cc (20 micrograms) of stat is injected and if the pain is not controlled, PCA is given by the patient. Reduction of pain after open Cholecystectomy. Timepoint: VRS score(Verbal Rating Score) in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated. Method of measurement: Through the Score Verbal Rating Scale (VRS). Nausea and Vomiting Score after open Cholecystectomy. Timepoint: Nausea and Vomiting in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated. Method of measurement: By Scoring N&V Score. Sedation Score after open Cholecystectomy. Timepoint: Sedation Score(Through the Ramsay relaxation Scale) in both groups at the time of study (in recovery,2,6,12,18 and 24) will be evaluated. Method of measurement: Through the Ramsay relaxation Scale. Ardabil University of Medical Sciences Approved 2019-06-09 Ethics committee of Ardabil University of Medical Sciences Ardebil University of Medical Sciences, Office Complex End of University Street Ardabil Ardabil Iran (Islamic Republic of)