Tenaculum Pain Control Study

NCT01421641 | Completed Phase 4 Results

• 1 other identifier: OHSU RES 7148
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Cervical Pain; Pelvic Pain

Keywords

Tenaculum; Pain; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intervention Pain

  after application of randomized intervention

• Tenaculum Placement Satisfaction

  After placement of the tenaculum

Study Arms (2)

Intracervical Lidocaine Injection

ACTIVE COMPARATOR

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

Topical Lidocaine Gel

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Lidocaine injection, paracervical blocker

Intracervical Lidocaine Injection

Topical Lidocaine Gel DRUG

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

Also known as: lidocaine gel, numbing gel

Topical Lidocaine Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy women
• Age 18 and over
• Indication for endometrial biopsy or IUD placement

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Neck Pain; Pelvic Pain; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

There are several limitations to this study, including potential selection bias, difficulty with blinding the intervention, timing of the intervention for maximal effect, and the limitations inherent in measuring pain.

Results Point of Contact

• Title: Paula Bednarek
• Organization: Oregon Health & Science University

bednarek@ohsu.edu

(503) 418-4500

Study Officials

• Paula Bednarek, MD MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 23, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-03

Locations

US (1)