Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy (-)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Akarawit Jitchanwichai, Mahidol University
ClinicalTrials.gov Identifier:
NCT01908738
First received: July 18, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Endometrial Biopsy
Abnormal Uterine Bleeding
Drug: paracervical block with 1%lidocaine
Drug: 10%lidocaine spray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy Under Oral Analgesic Drugs; A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • adverse effects of paracervical block versus lidocaine spray [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: paracervical block with 1%lidocaine

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)
Drug: 10%lidocaine spray
Placebo Comparator: receive placebo both paracervical block and spray
the third groups receive placebo both paracervical block and spray

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908738

Contacts
Contact: Akarawit Jitchanwichai, MD 66865796409 ascorbic_aj@hotmail.com
Contact: Thanapan Chu boon, Asst.Prof.Dr 66897338840 thanapan.c@psu.ac.th

Locations
Thailand
Akarawit Jitchanwichai Recruiting
Songkla, Hatyai, Thailand, 90110
Contact: Akarawit Jitchanwichai, MD    66865796409    ascorbic_aj@hotmail.com   
Principal Investigator: Akarawit Jitchanwichai, MD         
Sponsors and Collaborators
Mahidol University
  More Information

No publications provided

Responsible Party: Akarawit Jitchanwichai, faculty of medicine obstertic and gynecology, Mahidol University
ClinicalTrials.gov Identifier: NCT01908738     History of Changes
Other Study ID Numbers: 56-244-12-4-2
Study First Received: July 18, 2013
Last Updated: March 24, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Endometrial biopsy
paracervical block
Lidocaine spray
women
abnormal uterine bleeding

Additional relevant MeSH terms:
Uterine Hemorrhage
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Uterine Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014