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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

August 9, 2011
March 18, 2014
September 2011
May 2012   (final data collection date for primary outcome measure)
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.
Pain [ Time Frame: Data will be collected at the time of the procedure (day 1). ] [ Designated as safety issue: No ]
Pain will be measured by visual analog scale (VAS). Specific time points for pain will be assessed prior to speculum placement, after speculum placement, after randomized intervention, and after tenaculum placement.
Complete list of historical versions of study NCT01421641 on ClinicalTrials.gov Archive Site
  • 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)
Patient satisfaction [ Time Frame: Data will be collected at the time of the procedure (day 1). ] [ Designated as safety issue: No ]
Patient satisfaction will be assessed after tenaculum placement.
Not Provided
Not Provided
 
Tenaculum Pain Control Study
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Cervical Pain
  • Pelvic Pain
  • 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
  • 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
  • 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.
    Intervention: Drug: Intracervical Lidocaine Injection
  • 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)
    Intervention: Drug: Topical Lidocaine Gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01421641
OHSU RES 7148
No
Paula Bednarek, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Paula Bednarek, MD MPH Oregon Health and Science University
Oregon Health and Science University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP