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IRCT20180526039854N1 IRCT 2020-11-02 Islamic Azad University Evaluation of pain and satisfaction with local anesthesia in colposcopy and cervical biopsy The effect of paracervical block with lidocaine on analgesia in patients undergoing colposcopy and cervical biopsy 2020-08-10 anticipated 74 Complete https://irct.ir/trial/50697 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the current study, we used block randomization method. Each block size was 2 by 2, and in total 16 blocks were considered. The acceptable sequences for packages within each block were: 1) AABB, 2) ABAB, 3) BBAA, 4) BABA, 5) ABBA, and 6) BAAB. Then each were marked from 1 to 6 as above. After that the packages within blocks were sequentially numbered from 1 to 64. Participant were consecutively numbered from 1 to 180, based on the time of admission and hospital registration code, Blinding description: Two set of 74 sterile, colorless and ready to inject 10 cc syringes (2% lidocaine and normal saline for injection) were prepared and were labeled A and B before concealment. According to block randomization, each patients syringe A or B treatment. The patients, the nurses who administrated were blinded. Also, the physicians did not know which patients received the drug A or B. Hence, the patients, physicians, nurses, as well as data analyzer were blinded to the type of analgesic. 3 patients undergoing colposcopy and cervical biopsy. Intervention 1: Intervention group: Diclofenac anal suppository 100, 30 minutes before the procedure and then injection of 10 cc of 2% lidocaine at 3 and 9 o'clock around the cervix. Intervention 2: Control group: Diclofenac 100 anal suppository, 30 minutes before the procedure and then injection of 10 cc of normal saline 0.9% injection at 3 and 9 o'clock around the cervix. Yes - There is a plan to make this available What will be shared: Data collection form Only part of the data that contains information about the main outcome can be shared. When: After official publication To whom: Researchers working in scientific and academic institutions Conditions: Giving a written letter of commitment not to misuse the study data Where to obtain: Dr. Fahimeh Nokhostin fahimeh.nokhostin@yahoo.com How to obtain: Proposal Confirmed letter for proposal Ethical code Related international codes Comments:
public Fahimeh Nokhostin
Office of the Department of Obstetrics and Gynecology, Shahid Sadoughi Hospital, Sahid Ghandi boulevard, Safaeieh
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3183 3958 fahimeh.nokhostin@yahoo.com Islamic Azad University scientific Fahimeh Nokhostin
Office of the Department of Obstetrics and Gynecology, Shahid Sadoughi Hospital, Sahid Ghandi boulevard, Safaeieh
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3183 3958 fahimeh.nokhostin@yahoo.com Islamic Azad University Iran (Islamic Republic of) Females between 18-60 years old ASA Class I , II Candidate for colposcopy and cervical biopsy 18 years 60 years Female pregnant women Drug and psychotropic addiction History of taking neurological and analgesic drugs from one day before the procedure Severe systemic diseases (cardiac dis., kidney dis., etc.) History of allergy to anesthetics Dissatisfaction with the study Treatment - Drugs Placebo Intervention group: Diclofenac anal suppository 100, 30 minutes before the procedure and then injection of 10 cc of 2% lidocaine at 3 and 9 o'clock around the cervix Control group: Diclofenac 100 anal suppository, 30 minutes before the procedure and then injection of 10 cc of normal saline 0.9% injection at 3 and 9 o'clock around the cervix Average of pain score. Timepoint: During and 5 minutes after the procedure. Method of measurement: Pain Score (VAS 0-10). Satisfaction rate of the procedure. Timepoint: After the procedure. Method of measurement: Score 0-5. Islamic Azad University Approved 2020-08-09 Ethics committee of Islamic Azad University Of Yazd Research unit, Ali Ibn Abitaleb Medical School, Islamic Azad University Of Yazd, Shohada Gomnam boulevard, Safaeieh Yazd Yazd Iran (Islamic Republic of)