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OpenTrials
Completed

NCT Number: NCT02710305

Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

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Key information

Conditions

Pain Relief

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The infertile women who indicated for HSG

Exclusion criteria

  • contraindications to Hyoscine or lidocaine
  • known sensitivity to contrast media
  • abnormal uterine bleeding
  • genital tract infection
  • suspected pregnancy

Treatment and study plan

oral hyoscine butyl bromide tablets plus lidocaine cream

Drug

patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure

oral placebo tablets plus placebo cream

Drug

patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure

Primary outcomes

  1. Mean pain score during HSG

    Time frame: intraoperative

Secondary outcomes

  1. Mean pain score after HSG

    Time frame: 30 minutes

  2. rate of side effects

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

Acronym: HBTB

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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