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

NCT06398054 | Not Yet Recruiting Phase 4

• 1 other identifier: HYSTPAIN
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

  The primary objective of this study is to determine the effectiveness of the use of ibuprofen 400 mg alone or a combination of 400 mg ibuprofen and 20 mg Hyoscine N-Butil Bromide, one hour before office hysteroscopy, has a different impact on reducing pain in patients.

  During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure

Secondary Outcomes (4)

• Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

  During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure

• Use of Visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)

  5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure

• Measure of the level of anxiety (through STAI-Y1 items, with a score from 1 to 4, where: 1 = not at all and 4 = very much)

  During office hysteroscopy

• Rate of adverse effects (percentage of events collected)

  up to 24 hours

Study Arms (2)

Ibuprofen

PLACEBO COMPARATOR

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

Drug: Ibuprofen 400 mg; Drug: placebo

Ibuprofen plus HHB

EXPERIMENTAL

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

Drug: Ibuprofen 400 mg; Drug: Hyoscine N-Butil Bromide

Interventions

Ibuprofen 400 mg DRUG

Ibuprofen 400 mg tablet

Ibuprofen; Ibuprofen plus HHB

Hyoscine N-Butil Bromide DRUG

Hyoscine N-Butil Bromide 10 mg two tablets

Ibuprofen plus HHB

placebo DRUG

Two tablets

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Lorenzo Quirino

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Quirino

CONTACT

02. 63632349; lorenzo.quirino@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Upon confirmation of eligibility, subjects will be randomly assigned (with a 1:1 allocation as per a computer generated randomization list with the same number of patients in each group) into one of two treatment arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share