Tenaculum Pain Control Study

Oregon Health & Science University (OHSU)

Status and phase: Completed; Phase 4

Conditions: Pelvic Pain; Cervical Pain

Treatments: Drug: Topical Lidocaine Gel; Drug: Intracervical Lidocaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01421641

OHSU RES 7148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Intracervical Lidocaine Injection

Active Comparator group

Description:

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

Treatment:

Drug: Intracervical Lidocaine Injection

Topical Lidocaine Gel

Active Comparator group

Description:

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)

Treatment:

Drug: Topical Lidocaine Gel