Tenaculum Pain Control Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

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:

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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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.

Conditions

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Cervical Pain Pelvic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Intracervical Lidocaine Injection

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Topical Lidocaine Gel

Intervention Type DRUG

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

Interventions

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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 Type DRUG

Topical Lidocaine Gel

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

Intervention Type DRUG

Other Intervention Names

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Lidocaine injection, paracervical blocker lidocaine gel, numbing gel

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes