Hyoscine Butyl Bromide in Reducing Pain During HSG (HBTB-DIC)

Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG

Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Study Overview

• Status: Completed
• Conditions: Pain Relief With HSG
• Intervention / Treatment: Drug: hyoscine butyl bromide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas
  • Please Select
    • Assiut, Please Select, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

The infertile women who indicated for HSG.

Exclusion Criteria:

• contraindications to Hyoscine or NSAID - known sensitivity to these drugs
• known sensitivity to contrast media
• abnormal uterine bleeding
• genital tract infection
• suspected pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure	Drug: hyoscine butyl bromide; oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure; Other Names: BUSCOPAN
Placebo Comparator: Group B; oral 2 tablets (PLACEBO) 30 minutes before the procedure	Drug: placebo; oral placebo; 2 tablets 30 minutes before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score during. hysterosalpingography by visual analog scale	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean pain score after hysterosalpingography	30 minutes

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: ahmed abbas, MD, Woman health hospital Assiut

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 11, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Mydriatics; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: HS2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided