Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy

February 20, 2017 updated by: Akarawit Jitchanwichai, Mahidol University

Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy Under Oral Analgesic Drugs; A Randomized Controlled Trial

The purpose of this study to determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Study Overview

Detailed Description

Participants : This study was conducted prospectively at the outpatient clinic, Department of Obstetrics and Gynecology, Songklanagarind Hospital.

Inclusion criteria : The women who had abnormal uterine bleeding and indication for endometrial biopsy were enrolled.

Exclusion criteria : included 1) contraindications to NSAID or Lidocaine - known sensitivity to these drugs; 2) pregnancy; 3) genital tract infection; 4) coagulation disorder; and 5) unstable vital signs.

Sample size calculation : Sample size was calculated by assuming the different mean pain score of each groups performing the endometrial biopsy to be 1. To evidence this difference with a power of 80% and a 5% level of significance, a need was calculated with 36 women in each group and for total was 108 women.

Z α/2 = Type I error(alpha error) α = 0.05 >> 1.96 Z β = Type II error(beta error) β = 0.2 >> 0.84

  • Variance of mean pain score between procedure and post procedure 15 minutes = 1.5 µ0 = Mean pain score in group 1 µ1 = Mean pain score in group 2 µ0 - µ1 = Different of mean pain score in between each groups = 1 **N = 2(1.5)2(1.96 + 0.84)2/(1)2 = 35.3 N = 36 per group

Study procedures :

  1. Explain the steps of the procedure to the patient and counseling regarding rational and risks/benefits. Obtain consent for the procedure. Perform bimanual exam to determine uterine size and position.
  2. After signing a written informed consent, the women were randomly allocated to 3 groups. All women will receive Acetaminophen 500 mg and Ibuprofen 400 mg before procedure 30 minutes.

    The first groups receive paracervical block with 1%lidocaine and 0.9%NSS spray(placebo), the second groups receive 10%lidocaine spray and paracervical block with 0.9%NSS(placebo) and the third groups receive placebo both paracervical block and spray. Both women and researcher associate were blinded to group allocation. The 1%lidocaine, 10%lidocaine spray and both placebos were prepared in sequentially numbered sealed opaque envelops according to the table of random numbers by an independent pharmacist.

  3. The time that start oral medication and vital signs before starting procedure were recorded.
  4. Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. Then administer paracervical block by using local anesthetic drug 5 ml. injects at cervical area 3 and 9 O'clock, depth 0.5-1 cm., 2.5 ml. each sides. After that use anesthetic spray sprays at cervix for 1 times and wait for 3 minutes.
  5. Endometrial biopsy was performed by using a 3-mm EndosamplerTM (MedGyn EndosamplerTM, MedGyn Product Inc, IL, USA). If insertion of EndosamplerTM failed, a tenaculum was applied to the anterior cervix to help for stabilization and counter-traction.
  6. After get the endometrial tissue sample, remove all equipments, checked and stopped bleeding. And record vital signs after finish the procedure.
  7. The form contained a visual analog scale for women to report their responses of pain at immediately after procedure and after that 15 minutes by using Numerical Rating Scale(NRS) were recorded.
  8. The women were assessed for adverse side effects or complications of procedure e.g. such as dizziness, nausea, vomiting, pelvic pain or others.
  9. Follow up appointment the women for pathological report result at PSU hospital and consider further management.

Expected outcomes :

To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Table. Pain score(NRS) immediately after procedure and 15 minutes Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Control group(Placebo) Pain score immediately Pain score 15 minutes A secondary goal of this study was to determine the adverse effects of these methods(such as dizziness, nausea, vomiting, pelvic pain, bleeding).

Data analysis :

Data are presented as median (range) for quantitative variables and frequency for qualitative variables. Comparison between both groups was made by using the Chi-square test, Fisher's exact test and Mann-Whitney U test where appropriate with p<0.05 considered statistically significant. Statistical analysis was performed with the SPSS 17.0 package program (Statistical Package for Social Science; SPSS Inc., Chicago, IL, USA).

Ethical consideration :

  • Inform consent will be obtained before study procedure.
  • The study will not detrimental patients or treatment outcomes.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hatyai
      • Songkla, Hatyai, Thailand, 90110
        • Akarawit Jitchanwichai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • abnormal uterine bleeding women
  • indicated for endometrial biopsy

Exclusion Criteria:

  1. contraindications to NSAID or Lidocaine - known sensitivity to these drugs
  2. pregnancy
  3. genital tract infection
  4. coagulation disorder
  5. unstable vital signs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)
first groups receive paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)

To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Pain score(NRS) immediately after procedure and 15 minutes Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Control group(Placebo) Pain score immediately Pain score 15 minutes

Experimental: 10%lidocaine spray and paracervical block with 0.9%NSS
the second groups receive 10%lidocaine spray and paracervical block with 0.9%NSS(placebo)
Placebo Comparator: receive placebo both paracervical block and spray
the third groups receive placebo both paracervical block and spray

To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Pain score(NRS) immediately after procedure and 15 minutes Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Control group(Placebo) Pain score immediately Pain score 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial
Time Frame: up to 12 months

measurement outcome by record Pain score(NRS)[Numberical rating scale 0-10] immediately after procedure and 15 minutes after procedure in all groups Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Group 3 Control group(Placebo) Pain score immediately and Pain score 15 minutes were compared between group by using statistic analysis to indentify the significant of decreasing Pain score for pain relief during endometrial biopsy.

And after that the result will used to determine effectiveness of each groups[ paracervical block, lidocaine spray and only oral analgesic drugs.

up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effects of paracervical block versus lidocaine spray
Time Frame: up to 12 months
A secondary goal of this study was to determine the adverse effects of these methods(such as dizziness, nausea, vomiting, pelvic pain, bleeding) by recording the adverse effects outcome of each groups and report the result.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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