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IRCT20220812055663N1 IRCT 2022-11-14 Arak University of Medical Sciences Comparing the effect of of Remifentanil and Apotel on postoperative pain in Total knee arthroplasty patients Comparing the effect of of Remifentanil and Apotel on postoperative pain in Total knee arthroplasty patients (a clinical trial study) 2022-09-23 anticipated 62 Complete https://irct.ir/trial/65301 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All knee joint replacement candidates, referred to Amir-al-Momenin Arak Hospital, who meet the inclusion criteria for the study, will be divided as a randomized block design by the in charge anesthesiologist; in the form of quadruple blocks: ABB, ABAB, BABA, ABBA, BAAB, BBAA; into two groups of Remifentanil and Apotel, Blinding description: In order to comply with Blindness, after obtaining informed consent from patients who are candidates for knee joint replacement, they are divided into two groups with equal numbers: A (Apotel) and B (Remifentanil). In group A (Apotel), 1 gram of Apotel in 100 cc of normal saline is placed on the infusion pump (syringe pump) by the anesthesiologist in charge of the plan to be infused within one hour after the surgery, and in group R (remifentanil) in which patients receive 0.5 gr/kg/min remifentanil in 100cc of normal saline infusion on a syringe pump to be infused within one hour during the surgery and blindness is also observed. None of the patients are aware of their placement in the study group, nor is the intern who is responsible for filling out the plan's questionnaire. 2-3 Knee joint arthritis. Intervention 1: Intervention group: Group A (Apotel): For patients in this group, after spinal anesthesia and hemodynamic stability of the patient and the start of surgery, 1 gram of Apotel is poured into 200cc of normal saline and it is infused for the patient within one hour of the beginning of surgery. After the end of the surgery and ensuring stable hemodynamics and confirmation of anesthesiologist, the patient is transferred to the recovery room and the pain pump is prepared by the in charge anesthesiologist at a speed of 8cc/hr until 12 hours after the surgery. 16 mg of dexamethasone, 8 mg of ondansetron and 10 mg of morphine will be poured inside the pain pump and its volume will be increased to 100 cc by normal saline and 2 grams of Apotel will be added to this solution. Intervention 2: Intervention group: In group R (remifentanil), after performing spinal anesthesia and ensuring hemodynamic stability and confirming anesthesia, and after the start of surgery, 0.5μ⁄ (kg/min) of remifentanil will be infused within one hour of the beginning of surgery. At the end of surgery and ensuring stable hemodynamics and confirmation of anesthesiologist, the patient will be transferred to the recovery room and the pain pump will be prepared by the in charge anesthesiologist at a speed of 8cc/h until 12 hours after surgery. In both groups, 16 mg of dexamethasone and 8 mg of ondansetron, 10 mg of morphine will be placed inside the pain pump, and its volume will be increased to 100 cc by normal saline. In addition to the basic composition of the pain pump that was mentioned, 2 mg of remifentanil equivalent to 1 vial will be placed inside the pain pump under the supervision of an anesthetist. Yes - There is a plan to make this available What will be shared: All clinical trial information, including participant data, study protocol, statistical analysis map, informed consent clinical study report, etc., can be shared after de-identifying participants. When: 6 months after the results are published To whom: Study data will be publicly accessible. Conditions: Documentation can be used for retrospective research or review article if publishing rights are preserved and the source is cited. Where to obtain: By sending an email to gmoghaddam_ali@arakmu.ac.ir How to obtain: The aforementioned request will be reviewed by the authorities and concessionaires of this trial within a maximum period of one week. Comments:
public Seyed Ali Golrokh Moghadam
Arak University of Medical sciences, Basij Sq, Sardasht
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3520 gmoghaddam_ali@arakmu.ac.ir Arak University of Medical Sciences scientific Alireza Kamali
Arak University of Medical Sciences, Basij Sq., Sardasht
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3532 Alikamaliir@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All candidate patients for knee joint replacement surgery referred to Amir-al-Momenin Hospital in Arak Patients in the age range of 18 to 60 years All patients undergo knee joint replacement by arthroplasty method Patients have informed consent 18 years 60 years Both All patients whose duration of surgery is more than 150 minutes All patients in whom spinal anesthesia fails and have to undergo general anesthesia Patients with ASA class 3 and 4 sensitivity/allergy to local anesthetics, Apotel and opioids The patient has an underlying heart, lung, liver, kidney, etc. disease M25.5 Pain in joint Treatment - Drugs Treatment - Drugs Intervention group: Group A (Apotel): For patients in this group, after spinal anesthesia and hemodynamic stability of the patient and the start of surgery, 1 gram of Apotel is poured into 200cc of normal saline and it is infused for the patient within one hour of the beginning of surgery. After the end of the surgery and ensuring stable hemodynamics and confirmation of anesthesiologist, the patient is transferred to the recovery room and the pain pump is prepared by the in charge anesthesiologist at a speed of 8cc/hr until 12 hours after the surgery. 16 mg of dexamethasone, 8 mg of ondansetron and 10 mg of morphine will be poured inside the pain pump and its volume will be increased to 100 cc by normal saline and 2 grams of Apotel will be added to this solution. Intervention group: In group R (remifentanil), after performing spinal anesthesia and ensuring hemodynamic stability and confirming anesthesia, and after the start of surgery, 0.5μ⁄ (kg/min) of remifentanil will be infused within one hour of the beginning of surgery. At the end of surgery and ensuring stable hemodynamics and confirmation of anesthesiologist, the patient will be transferred to the recovery room and the pain pump will be prepared by the in charge anesthesiologist at a speed of 8cc/h until 12 hours after surgery. In both groups, 16 mg of dexamethasone and 8 mg of ondansetron, 10 mg of morphine will be placed inside the pain pump, and its volume will be increased to 100 cc by normal saline. In addition to the basic composition of the pain pump that was mentioned, 2 mg of remifentanil equivalent to 1 vial will be placed inside the pain pump under the supervision of an anesthetist. Average post-operational Visual Analogue Scale(VAS) in patients. Timepoint: 2, 4, 8,12 and 24 hours after surgery. Method of measurement: Questionnaire. Average duration of postoperative analgesia. Timepoint: Up to 24 hours after the operation. Method of measurement: Questionnaire. Average opioid consumption after surgery. Timepoint: 24 hours after the operation. Method of measurement: Questionnaire. Average mean arterial pressure of patients in recovery. Timepoint: Duration of observation in recovery. Method of measurement: Monitor. Average pulse rate of patients in recovery. Timepoint: Duration of observation in recovery. Method of measurement: Monitor. Average SPO2 of patients in recovery. Timepoint: Duration of observation in recovery. Method of measurement: Monitor. Arak University of Medical Sciences Approved 2022-07-05 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Sq., Sardasht Arak Markazi Iran (Islamic Republic of)