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Completed

NCT Number: NCT01421641

Tenaculum Pain Control Study

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.

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Key information

Conditions

Cervical Pain Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracervical Lidocaine Injection

Drug

Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle

Other names: Lidocaine injection, paracervical blocker

Topical Lidocaine Gel

Drug

Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip

Other names: lidocaine gel, numbing gel

Primary outcomes

  1. Tenaculum Pain

    Time frame: After tenaculum placement

    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 outcomes

  1. Intervention Pain

    Time frame: after application of randomized intervention

    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)

  2. Tenaculum Placement Satisfaction

    Time frame: After placement of the tenaculum

    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)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 23, 2011
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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