]>
IRCT20221129056662N1 IRCT 2022-12-13 Shiraz University of Medical Sciences Evaluation the pain prevention effect of different surgical techniques in laparoscopic cholecystectomy . Pain preventive effects of different surgical techniques (low-pressure laparoscopy, intra operative ketorolac, and local bupivacaine administration) in female undergoing laparoscopic cholecystectomy. 2022-12-14 anticipated 120 Complete https://irct.ir/trial/67125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a double blinded RCT , Randomization description: Patients will randomly be divided into four groups, The randomization will be done by an independent external researcher .Randomization will be done by Excel , Blinding description: After takking informed consent, patients are randomly allocated into four groups . patients wont be informed about allocation . data collector and data assessor are unaware of allocation . Only the surgeon knows allocation . 3 laparoscopic cholecystectomy. Intervention 1: Intervention group: All the participants in this trial will go under laparoscopy with Co۲ pressure of ۱۵ mmHg except this group. This experimental group will experience a ۱۲ mmHg intra-abdominal CO۲ pressure . Intervention 2: Intervention group: The patients who would be allocated in this group will receive a concoction of bupivacaine ۲۰ mg( local anesthesia ) and dexamethasone ۸ mg. mixture will be rubbed on the site of the removed gall bladder before the termination of the operation. Intervention 3: Intervention group: Participants in this group will receive a single ۳۰ mg IV ketorolac just before the surgery ends. Intervention 4: Control group: these patients will get standard protocol of laparoscopic surgery . all of participators will under go laparoscopic cholecystectomy with four-port technique . Yes - There is a plan to make this available What will be shared: The data will be published after collection without mentioning personal data. When: After completing the study, the data will be accessible. To whom: The data will be accessible for researchers . Conditions: Using the results for planning and conduct additional research . Where to obtain: babak۱۳۸۰@gmail.com halimehg1378@gmail.com xalirezasadeghix@gmail.com How to obtain: 1month Comments:
public Babak Hosseine
Chamran Blvd ، District 1 ، Hafez hospital
Shiraz Iran (Islamic Republic of) 71946-34786 +98 71 3647 9531 babak۱۳۸۰@gmail.com Shiraz University of Medical Sciences scientific Babak Hosseine
Chamran Blvd ، District 1 ، Hafez hospital
Shiraz Iran (Islamic Republic of) 71946-34786 +98 71 3647 9531 babak۱۳۸۰@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Pt should be female . Age 18 - 65 BMI 18/5 - 30 ASA score I or II Score that received from pain catastrophizing questionnaire should be less than 30 . Patient should be without any underlying disease . Patient should be interested to participate in the study and complete the informed consent . 18 years 65 years Female Patient is a smoker . Patient take opium or opium component recently . Enable to speak in Persian . emergency surgery . Previous history of hepatobiliary surgery . Age less than 18 or more than 65 . patients that is male . Body mass index less than 18/5 or more than 30 . Patients with underlying disease like HTN ، DM and other . Patients with chronic diseases like liver failure ، renal failure ، respiratory disease ، heart problem and other . Addiction to tobacco or alcohol . Addiction to special drug . Treatment - Surgery Treatment - Drugs Treatment - Drugs N/A Intervention group: All the participants in this trial will go under laparoscopy with Co۲ pressure of ۱۵ mmHg except this group. This experimental group will experience a ۱۲ mmHg intra-abdominal CO۲ pressure . Intervention group: The patients who would be allocated in this group will receive a concoction of bupivacaine ۲۰ mg( local anesthesia ) and dexamethasone ۸ mg. mixture will be rubbed on the site of the removed gall bladder before the termination of the operation. Intervention group: Participants in this group will receive a single ۳۰ mg IV ketorolac just before the surgery ends. Control group: these patients will get standard protocol of laparoscopic surgery . all of participators will under go laparoscopic cholecystectomy with four-port technique . This study is designed to evaluate the effect of pain prevention effect of different surgical technique in post op pain of laparoscopic cholecystectomy. these effects will be evaluated according to score that patients get from pain questionnaire . Timepoint: patients complete the pain questionnaire in first follow up visit. this is 7 days after discharging from hospital . Method of measurement: pain questionnaire. Patient ' s daily performance. Timepoint: patients completed daily performance questionnaire at the first follow up visit . this visit will be 7 days after discharging . Method of measurement: daily performance questionnaire. Dose of analgesic. Timepoint: during discharge from hospital . Method of measurement: physician 's order that prescribed during hospitalization . Shiraz University of Medical Sciences Approved 2022-12-04 Ethics committee of Shiraz University of Medical Sciences iImam Hossein Sqe . Medical science university Shiraz Fars Iran (Islamic Republic of)