Clinical trial NCT06398054: A Study to Investigate the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy
Official title: Comparison of the Analgesic Efficacy of Ibuprofen Alone and Ibuprofen Plus Hyoscine-n- Butyl Bromide in Reducing Pain of Outpatient Hysteroscopy: a Randomized, Phase iv, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain
Keywords: hysteroscopy
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 .

Primary outcomes:
measure: Pain assessed by visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)
timeFrame: During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
Secondary outcomes:
measure: Visual analog pain score for pain assessment (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)
timeFrame: During office hysteroscopy procedure, 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
measure: Use of Visual analog pain score (10-point VAS, where 0 indicates no pain and 10 indicates the worst possible pain)
timeFrame: 5 minutes after office hysteroscopy procedure, 30 minutes after hysteroscopy procedure
measure: 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)
timeFrame: During office hysteroscopy
measure: Rate of adverse effects (percentage of events collected)
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: ASST Fatebenefratelli Sacco
name: Lorenzo Quirino
role: PRINCIPAL_INVESTIGATOR
References: