Phase 4 N=74 Randomized Single-blind Supportive Care

Tenaculum Pain Control Study

Cervical Pain · Pelvic Pain

Bottom Line

View on ClinicalTrials.gov: NCT01421641 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Tenaculum Pain — 12.3; 36.6 mm

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Intracervical Lidocaine Injection (Drug); Topical Lidocaine Gel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Tenaculum Pain	12.3; 36.6	—
SECONDARY Intervention Pain	20.4; 5.9	—
SECONDARY Tenaculum Placement Satisfaction	79.9; 74.6	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01421641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.