Tenaculum Pain Control Study

• ClinicalTrials.gov Identifier: NCT01421641
• Recruitment Status: Completed
• First Posted: August 23, 2011
• Results First Posted: April 21, 2014
• Last Update Posted: April 21, 2014
• Sponsor: Oregon Health and Science University
• Information provided by (Responsible Party): Paula Bednarek, Oregon Health and Science University

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Cervical Pain; Pelvic Pain	Drug: Intracervical Lidocaine Injection; Drug: Topical Lidocaine Gel	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• 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 Start Date: September 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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; Other Name: Lidocaine injection, paracervical blocker
Active Comparator: 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)	Drug: Topical Lidocaine Gel; Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip; Other Name: lidocaine gel, numbing gel

Outcome Measures

Primary Outcome Measures :

1. Tenaculum Pain [ Time Frame: After tenaculum placement ]
   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.

Secondary Outcome Measures :

1. Intervention Pain [ Time Frame: after application of randomized intervention ]
   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)
2. Tenaculum Placement Satisfaction [ Time Frame: After placement of the tenaculum ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

• Principal Investigator: Paula Bednarek, MD MPH; Oregon Health and Science University

More Information

• Responsible Party: Paula Bednarek, MD MPH, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01421641
• Other Study ID Numbers: OHSU RES 7148
• First Posted: August 23, 2011
• Results First Posted: April 21, 2014
• Last Update Posted: April 21, 2014
• Last Verified: March 2014

Keywords provided by Paula Bednarek, Oregon Health and Science University:

Tenaculum; Pain; Lidocaine

Additional relevant MeSH terms:

Pelvic Pain; Neck Pain; Pain; Neurologic Manifestations; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action