An interventional study of study group and control group in Infertility, Female, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged Up to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
Single blind randomized controlled study in which 80 patients coming for hystroscopy due to multiple indication as infertility, AUB and missed IUD were assigned for our study. Both Sample size and randomization were done by a computer program. Patients were classified into 2 groups, group 1 study group was subjected to intracervical injection of 5 mi of mepivacaine hydrochloride at position 3 and 9 of the vaginal portion of the cervix, and at least 5 minutes post injection before procedure done. The control group received NSAI injection 15 minutes before procedure and 5 ml of saline was injected in each side of cervix at 3 9 positions. Hystroscopy was done if an abnormality is detected an intervention was done. A descriptive scale of pain was done into mild, moderate or severe (that lead to interruption of the procedures).
Procedures:
All patients were subjected to:
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 80 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
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Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
patient put in dorsal postion , insertion of a speculum , sterilization of the cervix then intracervical injection of 5 ml mepicaine hydrochloride a local anasthetic as Carbocaine3%54 mg at site 3 and 9 using a 10 cm syringe
Procedure: study group
patient receives one tablet of NSAIDs (diclofenac sodium 50 mg )15 minutes before procedure then 5 ml of normal saline will be injected intracervical using 10 cm syringe then wait for 5 minutes before the procedure
Procedure: control group
local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
each patient receives one tablet of NSAIDs (diclofenac sodium 50 mg) and 5ml of a placebo in form of normal saline are injected intracervical 5 minutes before the procedure using 10 mm syringe.
tolerated hystroscopy
complete hystroscopy procedure with tolerable degree of pain.
Time frame: 30 minutes
occurrence of complication
symptoms of vasovagal as vomiting , sweeting and bradycardia
Time frame: 30 minutes
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Cairo University