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IRCT20160527028109N4 IRCT 2021-05-11 Iran University of Medical Sciences The effect of diluted ropivacaine in uterine distending fluid on pain after hysteroscopy surgeries The effect of diluted ropivacaine in uterine distending fluid on pain after hysteroscopy surgeries 2021-04-21 anticipated 60 Complete https://irct.ir/trial/55760 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study with a sample size of 60 people, 30 balls for intervention group A and 30 balls for intervention group B are placed inside a lottery container and then the balls are randomly removed from the container without replacement, so a sequence is created, Blinding description: The outcome assessor and data analyst will not know how the groups are assigned. We divide patients into two groups, A and B, and the outcome assessor and data analyzer identify the patient with A and B and do not know the nature of the groups. 3 Pain after hysteroscopic surgery in gynecological diseases. Intervention 1: Intervention group: Dilute rupivacaine (10 cc of half a percent rupivacaine per 1000 cc of normal saline per liter) is given as a dilating fluid during hysteroscopy. Intervention 2: Control group: They receive 10 cc of normal saline per 1000 cc of normal saline per liter as a dilating fluid during hysteroscopy. Yes - There is a plan to make this available What will be shared: Part of data like the main outcome or the same will be shared When: Access after 6 months after publication To whom: Data will be available for all researchers Conditions: It can be used for further research and improvement of surgery. Surgeons and gynecologists can use this data. Where to obtain: For receiving data please be contacted with mehdizadeh.a@iums.ac.ir How to obtain: limitless Comments:
public Kobra Tahermanesh
Rasool-e Akram Hospital, Niayesh St., Sttarkhan St., Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 6435 2562 tahermanesh.k@iums.ac.ir Iran University of Medical Sciences scientific Kobra Tahermanesh
Sattar Khan St., Maziar Mansouri St., Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 216651500 tahermanesh.k@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Women candidates for hysteroscopy treatment based on the opinion of a specialist Conscious consent to participate in the study 18 years 40 years Female Existence of pelvic inflammatory disease Having known cervical malignancy, severe uterine bleeding, cervical conization Need for intraoperative surgery due to complications (such as laparotomy due to uterine perforation) Having psychological or neurological disorders that affect pain perception. Allergy to rupivacaine Reluctance to continue cooperation while studying Patients with chronic diseases with pain such as low back pain, etc. who use continuous painkillers. Patients have previously had a tubectomy or have a bilateral obstruction of the tube. Patients with preoperative pelvic pain, dyspareunia, dysmenorrhea, with a vas score of 3 or higher. Treatment - Drugs Placebo Intervention group: Dilute rupivacaine (10 cc of half a percent rupivacaine per 1000 cc of normal saline per liter) is given as a dilating fluid during hysteroscopy. Control group: They receive 10 cc of normal saline per 1000 cc of normal saline per liter as a dilating fluid during hysteroscopy. Intensity and frequency of pain. Timepoint: 6, 12, 24 and 48 hours after hysteroscopy. Method of measurement: Questionnaire and patient file. Iran University of Medical Sciences Approved 2021-04-20 Iran University Of Medical Sciences Sattar Khan - Hazrat Rasool Akram Hospital Tehran Tehran Iran (Islamic Republic of)