Tenaculum Pain Control Study

Pelvic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01421641
• Other study ID #: OHSU RES 7148
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: March 18, 2014
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain
• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No