Tenaculum Pain Control Study
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Pain; Pelvic Pain
Intervention: Intracervical Lidocaine Injection (Drug); Topical Lidocaine Gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s): Paula Bednarek, MD MPH, Principal Investigator, Affiliation: Oregon Health and Science University
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Primary outcome: Tenaculum Pain
Secondary outcome: Intervention PainTenaculum Placement Satisfaction
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Oregon Health & Science University, Portland, Oregon 97239, United States
Additional Information
Starting date: September 2011
Last updated: March 18, 2014
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