Optimizing Analgesia for Endometrial Biopsy

Optimizing Analgesia for Endometrial Biopsy: A Prospective, Randomized Comparative Study

Comparison of the effectiveness of intrauterine lidocaine-paracervical block-dexketoprofen tromematol- lidocaine spray in endometrial biopsy analgesia

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Analgesic

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gaziosmanpaşa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• women aged 18-75 needs endometrial biopsy

Exclusion Criteria:

• women with allergies to prilocaine, lidocaine or dexketoprofen trometamol
• women with a history of severe uncontrolled cardiovascular disease, diabetes mellitus, pregnancy, vaginal, cervical, or pelvic infection, cervical cancer, or severe cervical stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients using intrauterine lidocaine for analgesia	Drug: Analgesic; comparing the effectiveness of analgesics in endometrial biopsy
Active Comparator: Patients using oral dexketoprofen for analgesia	Drug: Analgesic; comparing the effectiveness of analgesics in endometrial biopsy
Active Comparator: Patients using cervical lidocaine spray for analgesia	Drug: Analgesic; comparing the effectiveness of analgesics in endometrial biopsy
Active Comparator: Patients using paracervical block with prilocaine for analgesia	Drug: Analgesic; comparing the effectiveness of analgesics in endometrial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing analgesics in endometrial biopsy using The Visual Analogue Scale (VAS).	post operative VAS scores will be compared for each drug.The VAS measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). In this context, higher scores represent worse results.	1 hour

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: pain management; endometrial biopsy; intrauterine lidocaine
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: GaziosmanpasaTREHes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No