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

ASST Fatebenefratelli Sacco

Status and phase: Not yet enrolling; Phase 4

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06398054

HYSTPAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

190 participants in 2 patient groups, including a placebo group

Ibuprofen

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Drug: Ibuprofen 400 mg

Ibuprofen plus HHB

Experimental group

Description:

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

Treatment:

Drug: Hyoscine N-Butil Bromide

Drug: Ibuprofen 400 mg