A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy

NCT ID: NCT06398054

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-10-01

Brief Summary

For outpatient hysteroscopy (OH), it is recommended to take a standard dose of NSAIDs or more hyoscine-n butyl bromide (HBB) an hour prior to the procedure to minimize pain during the first postoperative hour. As there is currently no clear consensus in the literature regarding the best approach to pain management associated with office hysteroscopy procedures. This Phase 4 study is being conducted to evaluate the effectiveness of oral ibuprofen alone and in combination with HBB to determine the most appropriate strategy for improving pain perception in outpatients.

Detailed Description

This is a randomized, phase IV, double-blind, placebo-controlled clinical trial.

The subjects will be randomly assigned into one of two treatment arms:

• Group A (Ibuprofen ): will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to HBB)
• Group B (Ibuprofen plus HHB): will assume one tablet of ibuprofen 400 mg plus two tablets of HHB 10 mg.

The purpose of this study is to evaluate the effectiveness of oral ibuprofen alone and in combination with HBB to determine the most appropriate strategy for improving pain perception in outpatients.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ibuprofen

will receive one tablet of ibuprofen 400 mg and two tablets of placebo (similar in size, structure and colour to Hyoscine N-Butil Bromide)

Group Type: PLACEBO_COMPARATOR

Ibuprofen 400 mg

Intervention Type: DRUG

Ibuprofen 400 mg tablet

placebo

Intervention Type: DRUG

Two tablets

Ibuprofen plus HHB

will assume one tablet of ibuprofen 400 mg plus two tablets of Hyoscine N-Butil Bromid 10 mg.

Group Type: EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type: DRUG

Ibuprofen 400 mg tablet

Hyoscine N-Butil Bromide

Intervention Type: DRUG

Hyoscine N-Butil Bromide 10 mg two tablets

Interventions

Ibuprofen 400 mg

Ibuprofen 400 mg tablet

Intervention Type: DRUG

Hyoscine N-Butil Bromide

Hyoscine N-Butil Bromide 10 mg two tablets

Intervention Type: DRUG

placebo

Two tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• female patients older than 18 years who signed informed consent;
• patients who need an office hysteroscopy for their diagnosis or treatment. Those indications included postmenopausal endometrial thickening (over 4 mm), metrorrhagia, sonographic suspicion of endometrial polyps or myomas, Essure device insertion, and endometrial biopsy

Exclusion Criteria

• women with a possible pregnancy, ongoing vaginal bleeding, lower genital tract infection, gestational trophoblastic disease, asthma, hepatitis, renal failure, lactation, previous cervical surgery, or oversensitivity to one of the agents or their elements;
• patients suffering from neuropathic pain or other conditions that can impact on the perception of pain;
• individuals who use antidepressant, anxiolytics or other drugs/supplements that may have an impact on the perception of pain;
• contraindications to the use of ibuprofen and/or Hyoscine N-Butil Bromide .

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Quirino

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenzo Quirino

Role: PRINCIPAL_INVESTIGATOR

ASST Fatebenefratelli Sacco

Central Contacts

Lorenzo Quirino

Role: CONTACT

lorenzo.quirino@asst-fbf-sacco.it

02. 63632349

Other Identifiers

HYSTPAIN

Identifier Type: -

Identifier Source: org_study_id