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IRCT138903093706N3 IRCT 2010-09-21 Research Deputy of Tabriz University of Medical Sciences Effect of lidocaine gel on pain from copper IUD insertion: A randomized controlled trial Effect of lidocaine gel on pain from copper IUD insertion: A randomized controlled trial 2010-09-23 anticipated 96 Complete https://irct.ir/trial/3797 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A pain from copper IUD insertion. Intervention 1: Group 3 will get no intervention. Intervention 2: Group 1: lidocaine 2% gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion. Intervention 3: Group 2: lubricant gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion. http://www.indianjmedsci.org/article.asp?issn=0019-5359;year=2010;volume=64;issue=8;spage=349;epage=355;aulast=Mohammad-Alizadeh-Charandabi EFFECT OF LIDOCAINE GEL ON PAIN FROM COPPER IUD INSERTION:<br /> A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL<br /> MOHAMMAD-ALIZADEH-CHARANDABI S, SEIDI S, KAZEMI F<br /> CONTEXT: Insertion pain or fear of it may make women hesitate to use the intrauterine device (IUD); a long-term, reversible, highly-effective contraception method. Further study has been recommended on the effects of lidocaine (xylocaine) gel on IUD insertion pain in the recent Cochran review. <br /> AIMS: To determine the effect of lidocaine gel on pain from TCu-380A<br /> IUD insertion. <br /> MATERIALS AND METHODS: At a health center in Tabriz, Iran, 96 women were allocated into 3 groups using block randomization with<br /> 6 and 9 block sizes considering allocation concealment. In 1st<br /> and in the 2nd group, lidocaine 2% gel insertion, and the 3rd, lubricant gel was placed in the cervical canal 1 minute before an IUD<br /> group got no intervention. Immediately after IUD insertion, pain<br /> during the insertion was measured using 0-10 cm visual analogue scale. <br /> STATISTICAL ANALYSIS USED: Kruskal-Wallis and linear regression in SPSS-13 were used to identify effect of lidocaine gel on the pain. RESULTS: Overall, the mean pain score was 3.5 ±1.8. In univariate analysis, there was no significant difference in pain scores between<br /> the 3 groups. Also, results of linear regression model by controlling effect of the possible confounding showed no significant effect of lidocaine gel on the insertion pain. The mean pain score in the lidocaine group was 0.39 less than the no intervention group, but it was not significant (95%CI of the difference: -1.3, 0.57). CONCLUSIONS: Use of 2% lidocaine gel into the cervical canal has no effect on reducing overall pain during IUD insertion.<br /> Key words: Copper IUD, IUD insertion, lidocaine, pain
public Farideh Kazemi
Golgasht St.
Tabriz Iran (Islamic Republic of) +98 81 1254 9670 f.kazemi21@gmail.com Tabriz university of medical sciences scientific Sakineh Mohammad-Alizadeh Charandabi
Faculty of Nursing and Midwifery, South Shariati
Tabriz Iran (Islamic Republic of) +98 41 1477 2699 alizades@tbzmed.ac.ir , smoalch@yahoo.com Tabriz University of Medical Sciences, Faculty of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria: All IUD clients of Bavafa health center who have no IUD contraindication, including: Pregnancy, puerprium sepsis, pelvic inflammatory disease or sexually transmitted infections (currently or in past 3 months), known or suspected uterine or cervical cancer, unknown genital abnormal bleeding, uterine fibroids and tumors causing deformity in uterus. Exclusion criteria: any problem during IUD insertion for any reason; in this case another gel with the same number will be replaced. 15 years 48 years Female Z30.1 Insertion of (intrauterine) contraceptive device N/A Prevention Prevention Group 3 will get no intervention. Group 1: lidocaine 2% gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion Group 2: lubricant gel will be placed in the cervical canal by a sterile swab one minute before IUD insertion. Pain severity. Timepoint: Immediately after IUD insertion. Method of measurement: 10 cm visual analog scale. Research Deputy of Tabriz University of Medical Sciences Approved Research deputy of Tabriz university of medical sciences Golgasht St. Tabriz Iran (Islamic Republic of)