Pain Management, Cervical Preparation
Conditions
Brief summary
This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D&E) to paracervical block.
Interventions
DRUGLidocaine Gel (2%)
DRUGLidocaine Paracervical Block (1%)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women 18 and older * Intrauterine pregnancy ≥16 weeks gestation * English speaking competency * Willing and able to sign consent forms * Agree to comply with study procedures
Exclusion criteria
* Women less than 18 years of age * IV conscious sedation * Known allergy to study medication (lidocaine) * Any women not meeting inclusion criteria above will be excluded from participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | Intraoperative; Immediately (0-30 seconds) following cervical dilation | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anticipated Pain Measured by Visual Analogue Scale | Preoperative; 30 minutes prior to procedure | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
| Baseline Pain Measured by Visual Analogue Scale | Immediately prior to procedure | Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
| Speculum Placement Measured by Visual Analogue Scale | Intraoperative; Immediately following speculum placement | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
| Overall Pain Measured by Visual Analogue Scale | Postoperative; Assessed once 10 minutes after procedure | Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-administered Gel Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure
Lidocaine Gel (2%) | 34 |
| Paracervical Block Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement
Lidocaine Paracervical Block (1%) | 35 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unsuccessful Dilator Procedure | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Self-administered Gel | Paracervical Block | Total |
|---|---|---|---|
| Age, Continuous | 28.7 years STANDARD_DEVIATION 7.87 | 27.2 years STANDARD_DEVIATION 7.14 | 27.9 years STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 23 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Gestational Age | 19 weeks | 19.4 weeks | 19.2 weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) White | 14 Participants | 19 Participants | 33 Participants |
| Region of Enrollment United States | 34 participants | 35 participants | 69 participants |
| Sex: Female, Male Female | 34 Participants | 35 Participants | 69 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 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Time frame: Intraoperative; Immediately (0-30 seconds) following cervical dilation
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-administered Gel | Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | 48.4 units on a scale | Standard Deviation 26 |
| Paracervical Block | Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion | 56.3 units on a scale | Standard Deviation 29 |
Secondary
Anticipated Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Time frame: Preoperative; 30 minutes prior to procedure
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-administered Gel | Anticipated Pain Measured by Visual Analogue Scale | 47.2 units on a scale | Standard Deviation 22 |
| Paracervical Block | Anticipated Pain Measured by Visual Analogue Scale | 58.7 units on a scale | Standard Deviation 18 |
Secondary
Baseline Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Time frame: Immediately prior to procedure
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-administered Gel | Baseline Pain Measured by Visual Analogue Scale | 2.6 units on a scale | Standard Deviation 55 |
| Paracervical Block | Baseline Pain Measured by Visual Analogue Scale | 6.6 units on a scale | Standard Deviation 10 |
Secondary
Overall Pain Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Time frame: Postoperative; Assessed once 10 minutes after procedure
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-administered Gel | Overall Pain Measured by Visual Analogue Scale | Overall Pain | 45.4 units on a scale | Standard Deviation 26.7 |
| Self-administered Gel | Overall Pain Measured by Visual Analogue Scale | Overall Experience | 65.2 units on a scale | Standard Deviation 30 |
| Self-administered Gel | Overall Pain Measured by Visual Analogue Scale | Provider Reported Ease of Insertion | 27 units on a scale | Standard Deviation 29 |
| Paracervical Block | Overall Pain Measured by Visual Analogue Scale | Overall Pain | 51.7 units on a scale | Standard Deviation 25.7 |
| Paracervical Block | Overall Pain Measured by Visual Analogue Scale | Overall Experience | 62.4 units on a scale | Standard Deviation 30 |
| Paracervical Block | Overall Pain Measured by Visual Analogue Scale | Provider Reported Ease of Insertion | 21 units on a scale | Standard Deviation 22 |
Secondary
Speculum Placement Measured by Visual Analogue Scale
Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.
Time frame: Intraoperative; Immediately following speculum placement
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-administered Gel | Speculum Placement Measured by Visual Analogue Scale | 24.7 units on a scale | Standard Deviation 22 |
| Paracervical Block | Speculum Placement Measured by Visual Analogue Scale | 31.2 units on a scale | Standard Deviation 25 |