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The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical Block | Experimental |
| |
| No Paracervical Block | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 1% Lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Visual Analogue Score Measuring Pain | We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:
| 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Kiley, MD MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic | Chicago | Illinois | 60611 | United States |
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July 2010- February 2011, Northwestern Medical Faculty Foundation
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracervical Block | IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa. |
| FG001 | No Paracervical Block | IUD insertion with no lidocaine injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracervical Block | |
| BG001 | No Paracervical Block | |
| BG002 | Total |
| 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 | Median Visual Analogue Score Measuring Pain | We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:
| Posted | Median | Full Range | units on a scale | 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes 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 | Paracervical Block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheila Krishnan Mody | University of California, San Diego | (619)543-6777 | smody@ucsd.edu |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | No Paracervical Block | 0 | 24 | 0 | 24 |
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| Aniline Compounds |
| D000588 | Amines |