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The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).
The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms.
Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes.
Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient.
During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine infusion | Experimental | 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. |
|
| Paracervical block only | Active Comparator | Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions. | Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable). | Immediately (time zero) at uterine aspiration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, M.D., M.P.H | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of the Columbia Willamette | Portland | Oregon | 96822 | United States | ||
| Oregon Health and Science University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16449111 | Background | Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. doi: 10.1097/01.AOG.0000194204.71925.4a. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Infusion | 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. |
| FG001 | Paracervical Block Only | Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Infusion | 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. |
| BG001 | Paracervical Block Only |
| 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 | The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions. | Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable). | Posted | Mean | Standard Deviation | mm | Immediately (time zero) at uterine aspiration |
|
Adverse event data was collected at procedure visit and follow up visit, 2 weeks post-procedure.
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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 | Lidocaine Infusion | 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immediate reaspiration | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Edelman | Oregon Health & Science University | 503-494-3666 | whru@ohsu.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine | Drug | Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. |
|
| Portland |
| Oregon |
| 97239 |
| United States |
Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Paracervical Block Only | Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | Paracervical Block Only | Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. | 0 | 40 | 0 | 40 | 3 | 40 |
| Needed antibiotics at follow up visit | Reproductive system and breast disorders | Systematic Assessment |
|
| Delayed reaspiration | Reproductive system and breast disorders | Systematic Assessment |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |