Paracervical Block
Conditions
Keywords
Hysteroscopy, Pain medication, Lidocaine, Office Procedures
Brief summary
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.
Interventions
DRUGLidocaine paracervical block
5cc 1% lidocaine injection in each paracervical region
DRUGNormal Saline
5cc Normal Saline injection in each paracervical region
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women eligible and scheduled for office hysteroscopic placement of essure devices
Exclusion criteria
* Planned secondary procedures * Lidocaine allergy * Repeat procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | During 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine Paracervical Block 10 cc of 1% Lidocaine injected in the paracervical region | 40 |
| Saline Placebo Injection 10 cc of Normal Saline as placebo injected in paracervical region | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to place device / procedure abort | 3 | 3 |
Baseline characteristics
| Characteristic | Saline Placebo Injection | Lidocaine Paracervical Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 36.4 years STANDARD_DEVIATION 4.1 | 34.2 years STANDARD_DEVIATION 4.5 | 35 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
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.
Time frame: During Procedure
Population: Intent to Treat Population (all participants assigned to lidocaine or saline).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lidocaine Group | Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | 4.15 Score on a scale | Standard Deviation 1.9 |
| Saline Placebo Group | Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure. | 3.38 Score on a scale | Standard Deviation 5.84 |
Comparison: A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.p-value: <0.001Regression, Linear