Managing Outpatient Hysteroscopy-associated Pain

Jagiellonian University

Status: Completed

Conditions: Pain; Hysteroscopic Surgery

Treatments: Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy; Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy; Procedure: ketoprofen for pain relief in office hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05801172

1072.6120.228.2021

Details and patient eligibility

About

Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.

Full description

A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.

Enrollment: 201 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18
• indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility

Exclusion criteria

• allergies to medications
• refusal to consent to the procedure or participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 3 patient groups

A (NSAID)

Active Comparator group

Description:

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy

Treatment:

Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy

Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy

B (A+infiltration anesthesia)

Active Comparator group

Description:

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy plus 20 ml 1% lidocaine in intracervical administration at the start of the procedure

Treatment:

Procedure: ketoprofen plus paracervical block anesthesia with lidocaine for pain relief in office hysteroscopy

Procedure: ketoprofen for pain relief in office hysteroscopy

C (A+paracervical block)

Active Comparator group

Description:

ketoprofen 100 mg intravenously 30 min. pre-office hysteroscopy 20 ml 1% lidocaine in pericervical administration at the start of the procedure

Treatment:

Procedure: ketoprofen plus infiltration anesthesia with lidocaine for pain relief in office hysteroscopy

Procedure: ketoprofen for pain relief in office hysteroscopy