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More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.
This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12 mL arm | Experimental | Intervention:
|
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| 20 mL arm | Active Comparator | Intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 mL paracervical block | Drug | Injection of 12 mL of lidocaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Immediately Following Dilator Insertion | The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Time of dilator insertion (less than 1 minute to assess pain) |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Pain Immediately Prior to Dilator Insertion | Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Up to 1 minute to complete survey |
| Patient Global Satisfaction Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34352829 | Derived | Shaw KA, Lerma K, Hughes T, Hastings C, Fok WK, Blumenthal PD. A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485. |
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No individual participant data will be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 12 mL Arm | Participants receive injection of 12 mL of lidocaine. |
| FG001 | 20 mL Arm | Participants receive injection of 20 mL of lidocaine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who were allocated to the intervention and for whom primary outcome measure data are available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 12 mL Arm | Participants receive injection of 12 mL of lidocaine. |
| BG001 | 20 mL Arm | Participants receive injection of 20 mL of lidocaine. |
| 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 Immediately Following Dilator Insertion | The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Median | Inter-Quartile Range | score on a scale | Time of dilator insertion (less than 1 minute to assess pain) |
|
Average approximately 45 minutes
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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 | 12 mL Arm | Participants receive injection of 12 mL of lidocaine. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Stanford University | 650-497-5175 | gynresearch@stanford.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 | Jul 24, 2018 | Jan 9, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D000773 | Anesthesia, Obstetrical |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
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The provider and staff will be aware of arm allocation, but participants will remain blinded.
| 20 mL paracervical block |
| Drug |
Injection of 20 mL of lidocaine |
|
Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").
| Up to 1 minute to complete survey |
| Total Procedure Time | Defined as time of speculum insertion | Up to 10 minutes |
| Physician-reported Ease of Insertion | Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult"). | Up to 1 minute to complete survey |
| Count of Participants With Procedural Complications | Up to 10 minutes |
| Count of Participants With Side Effects Related to Lidocaine Administration | Side effects were not necessarily considered to be adverse events by investigator. | Up to 10 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Anticipated Pain Immediately Prior to Dilator Insertion | Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable). | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Median | Inter-Quartile Range | score on a scale | Up to 1 minute to complete survey |
|
|
|
| Secondary | Patient Global Satisfaction Score | Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected"). | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Median | Inter-Quartile Range | score on a scale | Up to 1 minute to complete survey |
|
|
|
| Secondary | Total Procedure Time | Defined as time of speculum insertion | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Median | Inter-Quartile Range | minutes | Up to 10 minutes |
|
|
|
| Secondary | Physician-reported Ease of Insertion | Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult"). | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Median | Inter-Quartile Range | score on a scale | Up to 1 minute to complete survey |
|
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| Secondary | Count of Participants With Procedural Complications | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Count of Participants | Participants | Up to 10 minutes |
|
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| Secondary | Count of Participants With Side Effects Related to Lidocaine Administration | Side effects were not necessarily considered to be adverse events by investigator. | Participants who received the allocated intervention and for whom primary outcome data are available | Posted | Count of Participants | Participants | Up to 10 minutes |
|
|
|
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 20 mL Arm | Participants receive injection of 20 mL of lidocaine. | 0 | 48 | 0 | 48 | 0 | 48 |
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| Dizziness or lightheadedness |
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| Shaky legs |
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