Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine paracervical block | Experimental | 5cc 1% lidocaine injection in each paracervical region |
|
| Saline placebo injection | Placebo Comparator | 5cc Normal Saline injection in each paracervical region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine paracervical block | Drug | 5cc 1% lidocaine injection in each paracervical region |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation. | During Procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Chudnoff, MD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centennial Women's Center / Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20027030 | Derived | Chudnoff S, Einstein M, Levie M. Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol. 2010 Jan;115(1):26-34. doi: 10.1097/AOG.0b013e3181c51ace. |
Not provided
Not provided
Of the 80 patients that met inclusion and exclusion criteria, only 74 completed either the lidocaine or saline placebo single-injection. Patients were randomized 1:1.
This was a investigator-sponsored single site clinical trial. Patients were recruited based on physician referral at Montefiore Medical Center from March 2007 to June 2008. Patients were excluded from participation if they had a known allergy to lidocaine.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine Paracervical Block | 10 cc of 1% Lidocaine (10mg) injected in the paracervical region of patient as a single-injection nerve block before their procedure. |
| FG001 | Saline Placebo Injection | 10 cc of Normal Saline (10mg) as placebo injected in paracervical region of patient as a single-injection placebo before their procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine Paracervical Block | 10 cc of 1% Lidocaine injected in the paracervical region |
| BG001 | Saline Placebo Injection | 10 cc of Normal Saline as placebo injected in paracervical region |
| 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 | Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation. | Intent to Treat Population (all participants assigned to lidocaine or saline). | Posted | Mean | Standard Deviation | Score on a scale | During Procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine Paracervical Block | 10 cc of 1% (10mg) Lidocaine injected in the paracervical region |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Program Administrator | Montefiore Medical Center | 718-405-8526 | fheitor@montefiore.org |
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal Saline | Drug | 5cc Normal Saline injection in each paracervical region |
|
| 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 |
|
10 cc of 1% lidocaine injected in the paracervical region
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Saline Placebo Injection | 10 cc of Normal Saline (10mg) as placebo injected in paracervical region | 0 | 37 | 0 | 37 | 0 | 37 |
Not provided
Not provided