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IRCT20220108053667N1 IRCT 2022-02-19 Mashhad University of Medical Sciences Postoperative pain control by topical subcutaneous analgesic injection at the end of surgery Postoperative pain control by topical subcutaneous analgesic injection at the end of surgery 2022-01-08 anticipated 100 Complete https://irct.ir/trial/61299 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study uses from simple randomization using opaque SNOSE sealed envelopes (sequentially numbered, opaque, sealed envelopes). In this way, the letters A and B are prepared and printed by one of the team members and placed inside the envelope. The envelope closes and its contents are not visible from outside. Then, the purpose of the study is explained to the person who has the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and based on the contents of the envelope in the intervention group (A) or control ( B) enters, Blinding description: The specialist physician divides the patients into two groups based on a random method and injects analgesic agents subcutaneously at the end of surgery in the intervention group . 2,6,12,24 hours after the operation, the patient's pain in the ward is assessed and recorded by the nurse based on the vas. The nurse who evaluates the patients' pain in the ward and the doctor who completes the questionnaire are not aware of the prescribed treatment. 3 Pain control after surgery for ovarian malignancies. Intervention 1: Intervention group: In the intervention group, at the end of surgery, before closing the skin in the subcutaneous area, 0.2% topical ropivacaine is injected at the rate of 1 to 2 cc per centimeter of incision. Intervention 2: Control group: In this group, subcutaneous injection is not performed at the end of surgery. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: 6 months after the publication of the results To whom: For researchers working in academic institutions Conditions: The results and documentation of the study can also be used by experts outside of academic centers Where to obtain: Email the person in charge of the scientific respondent. Dr. Maryam Esmaeilpour esmailpoorm2@yahoo.com How to obtain: Request the following email address to send the information within a week. esmailpoorm2@yahoo.com Comments:
public Marjaneh Farazestanian
Gynecology department, Ghaem hospital, Ahmad Abad Blvd.
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 FarazestanianM@mums.ac.ir Mashhad University of Medical Sciences scientific Maryam Esmaeilpour
Gynecology department, Ghaem hospital, Ahmad Abad Blvd.
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 esmailpoorm2@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients aged 40-60 years BMI = 25-30 without previous history of laparotomy ovarian mass with ultrasound, CT scan (solid cystic masses, papillary projection, abdominal ascites, parietal nodules, etc.) and tumor marker based on malignancy ( High levels of markers CA125 and CEA) laparotomy with midline incision average operation time of 60 to 90 minutes 40 years 60 years Female History of severe heart disease anemia liver disease kidney disease anesthetic allergy history of hypotension or hypertension C56 Malignant neoplasm of ovary Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, at the end of surgery, before closing the skin in the subcutaneous area, 0.2% topical ropivacaine is injected at the rate of 1 to 2 cc per centimeter of incision. Control group: In this group, subcutaneous injection is not performed at the end of surgery Pain score of patients after surgery. Timepoint: 2, 6, 12 and 24 hours after surgery. Method of measurement: Patients' pain is measured based on Visual Analog Scale. Recurrence of intestinal function. Timepoint: 12 and 24 hours after surgery. Method of measurement: Questions from the patient and patient file information. Opioid use to control pain. Timepoint: 2,6,12,24 hours post operation. Method of measurement: patient file information. Diclofenac suppository and acetaminophen injection for pain control. Timepoint: 2,6,12,24 hours post operation. Method of measurement: patient file information. Mashhad University of Medical Sciences Approved 2021-12-14 Ethics committee of Mashhad University of Medical Sciences Gynecology department, Ghaem hospital, Ahmad Abad Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)