Tenaculum Pain Control Study

Study Overview
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Brief Summary
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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: 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. 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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cervical Pain, Pelvic Pain

Intervention / Treatment
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* Drug: Intracervical Lidocaine Injection
* Drug: Topical Lidocaine Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intracervical Lidocaine Injection<br>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<br>* Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle<br>* Other names: Lidocaine injection, paracervical blocker;|
| Active Comparator: Topical Lidocaine Gel<br>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<br>* Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip<br>* Other names: lidocaine gel, numbing gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tenaculum Pain | 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. | After tenaculum placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Pain | 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) | after application of randomized intervention | 
| Tenaculum Placement Satisfaction | 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) | After placement of the tenaculum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenaculum, Pain, Lidocaine