Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control

NCT04572828 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-11-19

No results posted yet for this study

Summary

Office-based endometrial procedures are preferred over diagnostic dilation and curettage, nowadays. Paracervical block is single-shot nerve block that involve a one-time injection of local anesthetic adjacent to the utero-vaginal nerve plexus. Block provides analgesia during cervical pass of sampling device or manipulation of cervix. The paracervical block seems to work within few minutes after injection, but the optimal waiting time between injection and procedure is not known. In this randomized controlled study, it was aimed to determine the effect of waiting time of 1 minute and 3 minutes after paracervical block in endometrial sampling procedures using Pipelle cannula in terms of pain during and after the endometrial sampling and to compare with NSAIDs taken before the procedure.

Conditions

  • Office-based Endometrial Sampling Procedures

Interventions

PROCEDURE

Paracervical Block

Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 10 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle.

DRUG

550 mg Naproxen Sodium 60 minutes before the procedure

550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.

PROCEDURE

The capped needle

The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2020-11-03
Completion
2020-12-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572828 on ClinicalTrials.gov