Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control

Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Office-based Endometrial Sampling Procedures
• Intervention / Treatment: Procedure: Paracervical Block; Procedure: The capped needle; Drug: 550 mg Naproxen Sodium 60 minutes before the procedure

Detailed Description

120 participants who will undergo endometrial biopsy due to abnormal uterine bleeding will be enrolled in the study. The research will be conducted in 4 branches. These branches are Group 1: Waiting 1 Minute After Paracervical Block, Group 2: Waiting 3 Minute After Paracervical Block, Group 3: Control Group and Group 4: Waiting 60 Minute After Taking Oral NSAIDs. Thirty patients will be included in each group using power analysis of clinical studies in which endometrial biopsy techniques and pain comparisons were performed before [Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018;132(3):575-582.].

Pregnancy, pelvic infections, heavy bleeding disorders and NSAID allergy are the exclusion criteria.

In the study, the success of analgesic methods to be used for endometrial biopsy during and 30 minutes after the procedure will be compared. These methods include waiting 1 minute after the paracervical block is performed, waiting 3 minutes after the paracervical block is performed, and taking oral NSAIDs one hour before the procedure. All arms will be included 30 participants and control group with 30 participants is formed. The Numeric Pain Rating Scale (NPRS) system will be used for each case for pain during the procedure and 30 minutes after the procedure. According to this system, the fact that the participant have no pain will be evaluated as "0" point and having the most severe pain she can experience is "10" points.

Before procedure the cervix and vaginal vault will be prepared with povidone iodine. A vaginal speculum will be used for optimal exposure and manipulation of cervix. All procedures will be performed without grasping the cervix with a tenaculum. 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. 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. 550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.

For all procedures, low pressure sampling device (Pipelle Cannula, Medbar Medical Equipment Inc.)will be inserted to the cavity and endometrial samples will be obtained using a corkscrew rotation combined with a repeating cephalic-caudal motion. The procedure will be repeated twice in each case to ensure standardization. All endometrial biopsies will be performed by the same operator.

NPRS system will be explained to all groups after the procedure and the pain during the procedure will be requested to be graded. Thirty minutes after the procedure, the participants will be asked to rate current pain according to the NPRS system.

The study was approved by institutional ethics committee. Written informed consent will be obtained from all participants.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Ege University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Abnormal uterine bleeding

Exclusion Criteria:

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

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: Group 1: Waiting 1 Minute After Paracervical Block	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.; Other Names: 550 mg Naproxen Sodium 60 minutes before the procedure.
Active Comparator: Group 2: Waiting 3 Minute After Paracervical Block	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.; Other Names: 550 mg Naproxen Sodium 60 minutes before the procedure.
Placebo Comparator: Group 3: Control Group	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.
Active Comparator: Group 4: Waiting 60 Minute After Taking Oral NSAIDs	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): November 3, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 20-6.1T/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No