Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control

NCT04572828 | Completed DMC

• 1 other identifier: 20-6.1T/67
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• The Numeric Pain Rating Scale 0

  The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.

  Baseline (0 minute)

• The Numeric Pain Rating Scale 30

  The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain 30 minutes after procedure. According to this system, the fact that the participant has no pain is evaluated as "0" point and having the most severe pain she could experience is "10" points.

  30 minutes

Study Arms (4)

Group 1: Waiting 1 Minute After Paracervical Block

ACTIVE COMPARATOR

Procedure: Paracervical Block

Group 2: Waiting 3 Minute After Paracervical Block

ACTIVE COMPARATOR

Procedure: Paracervical Block

Group 3: Control Group

PLACEBO COMPARATOR

Procedure: The capped needle

Group 4: Waiting 60 Minute After Taking Oral NSAIDs

ACTIVE COMPARATOR

Drug: 550 mg Naproxen Sodium 60 minutes before the procedure

Interventions

Paracervical Block PROCEDURE

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.

Also known as: 550 mg Naproxen Sodium 60 minutes before the procedure.

Group 1: Waiting 1 Minute After Paracervical Block; Group 2: Waiting 3 Minute After Paracervical Block

550 mg Naproxen Sodium 60 minutes before the procedure DRUG

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

Group 4: Waiting 60 Minute After Taking Oral NSAIDs

The capped needle PROCEDURE

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.

Group 3: Control Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Abnormal uterine bleeding

You may not qualify if:

• Pregnancy
• Pelvic infections
• Heavy bleeding disorders
• NSAID allergy

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Obstetrical; Naproxen

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 1, 2020
• Study Start: September 28, 2020
• Primary Completion: November 3, 2020
• Study Completion: December 28, 2020
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)