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IRCT20200601047627N1 IRCT 2020-06-12 Kermanshah University of Medical Sciences The effect of painkillers on post-operative pain in gallbladder surgery. ApoLac Comparative Study of the Effect of Apotel and Ketorolac Injection on Post-operative Pain Management and Decrease in Side Effects in Patients undergoing Laparoscopic Cholecystectomy Surgery 2020-06-21 anticipated 96 Complete https://irct.ir/trial/48566 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients will be monitored for pain intensity and The need for painkiller injections within 24 hours. If patients have a score more than 4 in VAS : (0-10), they will be given Pethidine. The nausea and vomiting of patients will be examined during 12 hours after operation in hour 2, 4, 8 and 12 after operation. The score will be given in quantitative terms from 0 to 2. The score will be as follows : 0 : have not, 1 : tolerable and 2 : Intense-unbearable; Also gastritis and constipation will be reported too. The score will be as follows : 0 : have not, 1 : Can be fixed and 2 : continuous-Intense. Fever will always be checked and an antibiotic will be injected if necessary. In this study, Metoclopramide will be injected in case of nausea and Ondansetron in case of vomiting. Also, in case of gastritis, first Pantoprazole and in case of lack of control and need for a second drug, intravenous Ranitidine will be used; In case of constipation, the patient will be given Pidrolax, and if constipation persists (score 2), a colonoscopy should be performed. Finally, the patient's pain rate, the dosages of the painkiller, nausea, vomiting, fever, gastritis and constipation will be reported in each patient's checklist, and the data will be encrypted and entered into statistical software after collection, Randomization description: The statistical population includes cholecystectomy patients that using the systematic random allocation method, they will be divided into two equal groups (In terms of the number of participants) and will enter the research. The division of patients will be based on a table of random numbers and the number of patients entering the study. After entering the PACU, patients will be divided into two groups so that the first group receiving Apotel and the second group receiving Ketorolac, Blinding description: After the laparoscopic surgery, Patients will be divided into two groups so that the first group receiving Apotel and the second group receiving Ketorolac. (Instantly and 4 hours after surgery). Painkiller injections will begin into Recovery-room and by an anesthesiologist for patients. Patients in both intervention groups will not be informed of their medication. (1st Blinding). The treatment continue in the surgery ward by the specified nurse and under the supervision of a Principal Investigator. Patient follow-up within 24 hours; Evaluation of post-operative pain is performed in Instantly, 6, 12, 18 and 24 hours after surgery by an uninformed intern and by a visual Analogue scale (VAS). (2nd Blinding). Also patients will be given Preliminary information about VAS. N/A Cholecystitis. Intervention 1: Intervention group: Apotel recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection. Intervention 2: Intervention group: Ketorolac recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection. Yes - There is a plan to make this available What will be shared: Unlimited When: Unlimited To whom: Unlimited Conditions: Unlimited Where to obtain: Send e-mail to : surgery_department@kums.ac.ir How to obtain: Receive an e-mail from the applicant - Refer the request to the Principal Investigator (PI) - Get a response from the PI - Send data to the applicant (In case of agreement). Comments: Does not have.
public Mohammadhossein Safari
Surgery Dept., Imam Reza Hospital, Kermanshah Town.
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6301 mohammadhosein.safari@kums.ac.ir Kermanshah University of Medical Sciences scientific Arash Azadmehr
Surgery Dept., Imam Reza Hospital, Kermanshah Town.
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6301 surgery_department@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients with a history of cholecystitis Patients with biliary colic Patients with gallstone Patients with gallbladder polyp (more than 10 mm) 18 years 60 years Both Pregnant and lactating women Patients with impaired renal or dialysis function Patients with heart disease and who should take warfarin during treatment Patients with contraindications for opioids use Patients with hemorrhage especially gastrointestinal Bleeding Patients with high blood pressure history or History of bloodshed Patients with abuse drug Patients with asthma, lung disease and allergies to NSAIDs Patients with multiple trauma. Patients with a history of psychiatric disorders or unable to communicate verbally Patients who need anti-emetic or antihistamines before or after surgery. Patients who should be treated with medication from one month before the surgery or during the study period. Patients who should be used the painkiller 7 days before the surgery. Patients who has a drain after surgery. Patients with a Body Mass Index of more than 35 K80.13 Calculus of gallbladder with acute and chronic cholecystitis with obstruction Treatment - Drugs Treatment - Drugs Intervention group: Apotel recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection. Intervention group: Ketorolac recipient, 0 and 4 hours after surgery (2 times), PRN Pethidine, Intravenous injection. Check the rate of post-operative pain in both intervention group separately. Timepoint: Instantly after surgery (Recovery - before the intervention begins) + 6, 12, 18 and 24 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Visual analogue scale : (0-10). Check the dosages of the painkiller in both intervention group separately. Timepoint: 24 hours after surgery (Surgery wards - after the intervention). Method of measurement: Register in the checklist : Millilitre (Quantitative). Check the prevalence rate of nausea in both intervention group separately. Timepoint: 2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Visual analogue scale : (0-2). Check the prevalence rate of vomiting in both intervention group separately. Timepoint: 2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Visual analogue scale : (0-2). Check the rate of fever in both intervention group separately. Timepoint: 2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Register in the checklist : Centigrade (Quantitative). Check the prevalence rate of gastritis in both intervention group separately. Timepoint: 2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Visual analogue scale : (0-2). Check the prevalence rate of constipation in both intervention group separately. Timepoint: 2, 4, 8 and 12 hours after surgery (Surgery wards - after the intervention begins). Method of measurement: Visual analogue scale : (0-2). Kermanshah University of Medical Sciences Approved 2020-05-12 Ethics committee of Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Town. Kermanshah Kermanshah Iran (Islamic Republic of)