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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | after application of randomized intervention |
| Tenaculum Placement Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Bednarek, MD MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Exclusion criteria included 1) allergy to lidocaine or other local anesthetics; 2) pregnancy; 3) patients pre-medicated with misoprostol; and 4) patients with a chronic pain condition for which they were taking daily pain medications of any kind. The subjects were recruited, consented, and enrolled immediately prior to the procedure.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intracervical Lidocaine Injection | 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 |
| FG001 | Topical Lidocaine Gel | Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intracervical Lidocaine Injection | 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 |
| BG001 | Topical Lidocaine Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 4 subjects were excluded due to protocol violations | Posted | Mean | Standard Deviation | mm | After tenaculum placement |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intracervical Lidocaine Injection | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vasovagal reaction | Nervous system disorders | Systematic Assessment | After completion of the tenaculum study portion of the procedure, the patient had a vasovagal reaction at the time of insertion of the intrauterine device. This is not likely to be related to the study intervention, and resolved completely. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Bednarek | Oregon Health & Science University | (503) 418-4500 | bednarek@ohsu.edu |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Topical Lidocaine Gel | Drug | Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip |
|
|
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) |
| After placement of the tenaculum |
Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | mm | after application of randomized intervention |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | mm | After placement of the tenaculum |
|
|
|
| 0 |
| 37 |
| 1 |
| 37 |
| EG001 | Topical Lidocaine Gel | Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip | 0 | 37 | 0 | 37 |
|
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| Aniline Compounds |
| D000588 | Amines |