CompletedNCT01421641Updated Apr 21, 2014Results posted

Tenaculum Pain Control Study

A Phase 4 interventional study of Intracervical Lidocaine Injection and Topical Lidocaine Gel in Cervical Pain and Pelvic Pain, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by Oregon Health and Science University · Phase 4, Interventional, and Supportive care

Phase: Phase 4
Study type: Interventional
Enrollment: 74
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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:

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.
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.

Read the 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.

Conditions studied

Cervical Pain
Pelvic Pain

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Keywords

Tenaculum
Pain
Lidocaine

In context

Pelvic Pain

375 studies on the registry are indexed under Pelvic Pain; 83 are open to participants now.

This study's enrollment of 74 is above the median of 54 across 273 interventional studies indexed under Pelvic Pain.

Browse Pelvic Pain studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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

Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 74 participants (actual)

Study arms

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
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

Interventions

DrugIntracervical Lidocaine Injection
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
DrugTopical Lidocaine Gel
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

What researchers measure

Primary outcomes

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.
Time frame: After tenaculum placement

Secondary outcomes

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)
Time frame: after application of randomized intervention
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)
Time frame: After placement of the tenaculum

Results

Posted Apr 21, 2014

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.

Participant flow

We conducted a randomized, single-blinded clinical trial from August 2011 to May 2012 at the Center for Women's Health at Oregon Health \& Science University (OHSU; Portland, Oregon).We recruited women aged 18 years and older who were scheduled to undergo IUD placement or endometrial biopsy.

Participant flow — Overall Study
Milestone	Intracervical Lidocaine Injection	Topical Lidocaine Gel
Started	37	37
Completed	35	35
Not completed	2	2
Withdrew: Protocol violation	2	2

Outcome measures

PrimaryTenaculum 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.

Time frame:: After tenaculum placement
Reported as:: Mean · mm

Tenaculum Pain
mm	Intracervical Lidocaine Injection	Topical Lidocaine Gel
Tenaculum Pain	12.3 ± 17.4	36.6 ± 23.0

SecondaryIntervention 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)

Time frame:: after application of randomized intervention
Reported as:: Mean · mm

Intervention Pain
mm	Intracervical Lidocaine Injection	Topical Lidocaine Gel
Intervention Pain	20.4 ± 19.4	5.9 ± 8.6

SecondaryTenaculum 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)

Time frame:: After placement of the tenaculum
Reported as:: Mean · mm

Tenaculum Placement Satisfaction
mm	Intracervical Lidocaine Injection	Topical Lidocaine Gel
Tenaculum Placement Satisfaction	79.9 ± 22.7	74.6 ± 27.6

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intracervical Lidocaine Injection	—	0/37 (0%)	1/37 (2.7%)
Topical Lidocaine Gel	—	0/37 (0%)	0/37 (0%)

Most frequent other events

Most frequent other events
Event	Intracervical Lidocaine Injection	Topical Lidocaine Gel
vasovagal reactionNervous system disorders	1/37	0/36

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Intracervical Lidocaine Injection	Topical Lidocaine Gel	Total
<=18 years	0	0	0
Between 18 and 65 years	37	37	74
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Intracervical Lidocaine Injection	Topical Lidocaine Gel	Total
Mean	34.6 ± 12.2	33.7 ± 7.3	34.5 ± 9.9

Sex: Female, Male
Sex: Female, Male(Participants)	Intracervical Lidocaine Injection	Topical Lidocaine Gel	Total
Female	37	37	74
Male	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Intracervical Lidocaine Injection	Topical Lidocaine Gel	Total
United States	37	37	74

Study locations

1 site

Oregon Health & Science University
Portland, Oregon 97239, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01421641
Lead sponsor: Oregon Health and Science University
Responsible party: Paula Bednarek (MD MPH, Oregon Health and Science University) — Principal investigator
First posted: Aug 23, 2011
Start date: Sep 2011
Primary completion: May 2012
Completion: May 2012
Results posted: Apr 21, 2014
Last update: Apr 21, 2014

Study contacts

Paula Bednarek, MD MPH

principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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