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IRCT20210309050652N1 IRCT 2023-07-23 Shahre-kord University of Medical Sciences The effect of pregabalin on postoperative pain Evaluation of the effect of preoperative administration of pregabalin in comparison with co-administration of pregabalin and celecoxib on postoperative pain of laparoscopic cholecystectomy under general anesthesia 2021-11-27 anticipated 60 Complete https://irct.ir/trial/60156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated to three groups: A(control), B (only pregabalin) and C (combination of pregabalin and celecoxib), by block randomization with block size of 6. In each block, 2 patients of each group will be exist. The order of blocks will be determined randomly in A or B or C groups and subjects will be allocated sequentially in order of admission. The random allocation rule method was used for the determination of sequences using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed, Blinding description: Patients receive drugs (interventions or control groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and the evaluator nurse will be blind for the type of drugs. 3 Acute Postoperative Pain. Intervention 1: Intervention group: Patients receiving pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery) with celecoxib (capsule, 200 mg, product by Amin company, one time, oral, as single dose 2 hours before starting surgery). Intervention 2: Intervention group: Patients receiving only pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery). Intervention 3: Control group: They receive placebo. Yes - There is a plan to make this available What will be shared: The individual data of the study participants are considered and all the data can potentially be shared after the individuals are not identified. When: October 2022 To whom: Notification is allowed Conditions: Notification is allowed Where to obtain: Notification is allowed How to obtain: It does not have a specific process Comments: does not have
public Hossein Madineh
Shahre-kord University of Medical Sciences; Rahbar Boulevard
Shahrekord Iran (Islamic Republic of) 8818634141 +98 38 3232 4401 madineh@skums.ac.ir Shahre-kord University of Medical Sciences scientific Hossein Madineh
Shahre-kord University of Medical Sciences; Rahbar Boulevard
Shahrekord Iran (Islamic Republic of) 8818634141 +98 38 3232 4401 madineh@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Existence of ultrasonographic results confirming the presence of gallstones Symptomatic gallstone disease Candidate for elective surgery for laparoscopic cholecystectomy ASA Class 1 and 2 Age between 20 and 65 years Satisfaction to participate in the study 20 years 65 years Both Dissatisfaction with participating in the project History of diseases affecting vital signs including heart and lung failure Confirmed malignancy Need an open cholecystectomy People older than 65 years History of Addiction Occurrence of unwanted complications during the operation People with contraindications to anesthesia or opioids (patients with known hypersensitivity to the compounds of various anesthetics) Patients with inability to answer visual pain ruler questions K81.0 Acute cholecystitis Prevention Prevention Placebo Intervention group: Patients receiving pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery) with celecoxib (capsule, 200 mg, product by Amin company, one time, oral, as single dose 2 hours before starting surgery) Intervention group: Patients receiving only pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery) Control group: They receive placebo Patients' pain score based on visual and descriptive numerical pain questionnaire. Timepoint: Measurement of patients' pain, immediately after waking up in recovery, two and four hours after surgery. Method of measurement: Visual Analog Scale questionnaire. The need for Narcotic Analgesics after surgery. Timepoint: Immediately after waking up in recovery, two to four hours after surgery. Method of measurement: Mg Morphin. Hemodynamic symptoms. Timepoint: Immediately after waking up in recovery, two to four hours after surgery. Method of measurement: By measuring heart rate, pulse oximetry, respiratory rate, using blood pressure device. Shahre-kord University of Medical Sciences Approved 2021-10-26 Research Ethics Committee of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences; Rahbar Boulevard Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)