Tenaculum Pain Control Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01421641
First received: August 9, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used.

The researchers hypothesize that:

  1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
  2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

Condition Intervention Phase
Cervical Pain
Pelvic Pain
Drug: Intracervical Lidocaine Injection
Drug: Topical Lidocaine Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Effect of Intracervical Lidocaine Injection Versus Topical Lidocaine Gel on the Pain Experienced by Patients Undergoing Tenaculum Application to the Cervix at the Time of an Office Gynecologic Procedure

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Tenaculum Pain [ Time Frame: After tenaculum placement ] [ Designated as safety issue: No ]
    The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.


Secondary Outcome Measures:
  • Intervention Pain [ Time Frame: after application of randomized intervention ] [ Designated as safety issue: No ]
    Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)

  • Tenaculum Placement Satisfaction [ Time Frame: After placement of the tenaculum ] [ Designated as safety issue: No ]
    Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)


Enrollment: 74
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intracervical Lidocaine Injection
Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle.
Drug: Intracervical Lidocaine Injection
Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
Other Name: Lidocaine injection, paracervical blocker
Active Comparator: Topical Lidocaine Gel
Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip (this amount of lidocaine will be measured out prior to procedure)
Drug: Topical Lidocaine Gel
Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Other Name: lidocaine gel, numbing gel

Detailed Description:

Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Generally healthy women
  • Age 18 and over
  • Indication for endometrial biopsy or IUD placement

Exclusion Criteria:

  • Allergy to lidocaine or other local anesthetic
  • Pregnancy, known or suspected
  • Patients who are premedicated with misoprostol
  • Patients with a chronic pain condition for which the patient takes daily pain medication
  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: NCT01421641

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Paula Bednarek, MD MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Paula Bednarek, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01421641     History of Changes
Other Study ID Numbers: OHSU RES 7148
Study First Received: August 9, 2011
Results First Received: November 13, 2013
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Tenaculum
Pain
Lidocaine

Additional relevant MeSH terms:
Pelvic Pain
Neck Pain
Pain
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014