NCT06540599

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 9, 2024

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

August 2, 2024

Last Update Submit

August 7, 2024

Conditions

Analgesia

Keywords

endometrial biopsyintrauterine lidocainepain management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Patients using intrauterine lidocaine for analgesia

ACTIVE COMPARATOR
Drug: Analgesic

Patients using oral dexketoprofen for analgesia

ACTIVE COMPARATOR
Drug: Analgesic

Patients using cervical lidocaine spray for analgesia

ACTIVE COMPARATOR
Drug: Analgesic

Patients using paracervical block with prilocaine for analgesia

ACTIVE COMPARATOR
Drug: Analgesic

Interventions

AnalgesicDRUG

comparing the effectiveness of analgesics in endometrial biopsy

Patients using cervical lidocaine spray for analgesiaPatients using intrauterine lidocaine for analgesiaPatients using oral dexketoprofen for analgesiaPatients using paracervical block with prilocaine for analgesia

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged 18-75 needs endometrial biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 9, 2024

Record last verified: 2022-03

Locations

TU(1)