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The purpose of this study is to compare the pain level and level of discomfort with paracervical block versus no analgesia in women who present to the University of Texas (UT) Physicians Obstetrics and Gynecology Continuity Clinic, The UT Physicians Women's Center, and the UT Physicians Women's Center- Bellaire for IUD insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical block | Active Comparator | Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. |
|
| No analgesia | Active Comparator | IUD placement with no analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score as Assessed by a Visual Analogue Scale (VAS) | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | baseline (about 30 seconds after insertion of the speculum) |
| Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum) |
| Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela D Berens, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracervical Block | Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
| FG001 | No Analgesia | IUD placement with no analgesia. No analgesia: IUD placement without analgesia. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracervical Block | Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Score as Assessed by a Visual Analogue Scale (VAS) | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | Posted | Mean | Standard Deviation | units on a scale | baseline (about 30 seconds after insertion of the speculum) |
|
From time of speculum placement until the patient left the office (patient leaves office about 3-5 minutes after the procedure, for a total of about 15 minutes from speculum placement to leaving the office).
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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 | Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Lidocaine: Intrauterine device (IUD) placement with paracervical block with 1% lidocaine. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
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No Sham Block. Subjects had more variability in baseline pain scores (taken after speculum placement but prior to any procedure) than anticipated, and thus the study was underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela D. Berens, MD | The University of Texas Health Science Center at Houston | 713-500-6471 | Pamela.D.Berens@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2017 | Oct 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| No analgesia | Other | IUD placement without analgesia. |
|
| Intrauterine device (IUD) | Device | IUD placement with or without paracervical block with 1% lidocaine. |
|
| about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum) |
| No Analgesia |
IUD placement with no analgesia. No analgesia: IUD placement without analgesia. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prior delivery type | Count of Participants | Participants |
|
| Contraception History | Count of Participants | Participants |
|
| History of Infection | Count of Participants | Participants |
|
| Take pain medication | Count of Participants | Participants |
|
| OG001 | No Analgesia | IUD placement with no analgesia. No analgesia: IUD placement without analgesia. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. |
|
|
|
| Primary | Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | Posted | Mean | Standard Deviation | units on a scale | about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum) |
|
|
|
|
| Primary | Pain Score as Assessed by a Visual Analogue Scale | The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD). The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine). | Posted | Mean | Standard Deviation | units on a scale | about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum) |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No Analgesia | IUD placement with no analgesia. No analgesia: IUD placement without analgesia. Intrauterine device (IUD): IUD placement with or without paracervical block with 1% lidocaine. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |