Pain
Conditions
Keywords
paracervical block, abortion, dilation and evacuation, cervical preparation
Brief summary
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.
Detailed description
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.
Interventions
DRUG12 mL paracervical block
Injection of 12 mL of lidocaine
DRUG20 mL paracervical block
Injection of 20 mL of lidocaine
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The provider and staff will be aware of arm allocation, but participants will remain blinded.
Intervention model description
Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.
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 Immediately Following Dilator Insertion | Time of dilator insertion (less than 1 minute to assess pain) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Satisfaction Score | Up to 1 minute to complete survey | 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). |
| Total Procedure Time | Up to 10 minutes | Defined as time of speculum insertion |
| Anticipated Pain Immediately Prior to Dilator Insertion | Up to 1 minute to complete survey | Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable). |
| Count of Participants With Procedural Complications | Up to 10 minutes | — |
| Count of Participants With Side Effects Related to Lidocaine Administration | Up to 10 minutes | Side effects were not necessarily considered to be adverse events by investigator. |
| Physician-reported Ease of Insertion | Up to 1 minute to complete survey | Measured by VAS (0-100mm; 0 being very easy, 100 being very difficult). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 12 mL Arm Participants receive injection of 12 mL of lidocaine. | 45 |
| 20 mL Arm Participants receive injection of 20 mL of lidocaine. | 46 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet inclusion criteria | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | 12 mL Arm | Total | 20 mL Arm |
|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 7 | 31 years STANDARD_DEVIATION 7.8 | 31 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 25 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 66 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 27 Participants | 56 Participants | 29 Participants |
| Region of Enrollment United States | 45 Participants | 91 Participants | 46 Participants |
| Sex: Female, Male Female | 45 Participants | 91 Participants | 46 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 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
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).
Time frame: Time of dilator insertion (less than 1 minute to assess pain)
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 mL Arm | Pain Immediately Following Dilator Insertion | 41 score on a scale |
| 20 mL Arm | Pain Immediately Following Dilator Insertion | 49 score on a scale |
Secondary
Anticipated Pain Immediately Prior to Dilator Insertion
Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).
Time frame: Up to 1 minute to complete survey
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 mL Arm | Anticipated Pain Immediately Prior to Dilator Insertion | 51 score on a scale |
| 20 mL Arm | Anticipated Pain Immediately Prior to Dilator Insertion | 58 score on a scale |
Secondary
Count of Participants With Procedural Complications
Time frame: Up to 10 minutes
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 12 mL Arm | Count of Participants With Procedural Complications | 0 Participants |
| 20 mL Arm | Count of Participants With Procedural Complications | 0 Participants |
Secondary
Count of Participants With Side Effects Related to Lidocaine Administration
Side effects were not necessarily considered to be adverse events by investigator.
Time frame: Up to 10 minutes
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 12 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Metallic taste | 2 Participants |
| 12 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Ringing in ears | 2 Participants |
| 12 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Dizziness or lightheadedness | 1 Participants |
| 12 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Shaky legs | 0 Participants |
| 20 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Shaky legs | 1 Participants |
| 20 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Metallic taste | 3 Participants |
| 20 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Dizziness or lightheadedness | 6 Participants |
| 20 mL Arm | Count of Participants With Side Effects Related to Lidocaine Administration | Ringing in ears | 3 Participants |
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).
Time frame: Up to 1 minute to complete survey
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 mL Arm | Patient Global Satisfaction Score | 70 score on a scale |
| 20 mL Arm | Patient Global Satisfaction Score | 53 score on a scale |
Secondary
Physician-reported Ease of Insertion
Measured by VAS (0-100mm; 0 being very easy, 100 being very difficult).
Time frame: Up to 1 minute to complete survey
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 mL Arm | Physician-reported Ease of Insertion | 27 score on a scale |
| 20 mL Arm | Physician-reported Ease of Insertion | 17 score on a scale |
Secondary
Total Procedure Time
Defined as time of speculum insertion
Time frame: Up to 10 minutes
Population: Participants who received the allocated intervention and for whom primary outcome data are available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 12 mL Arm | Total Procedure Time | 5.5 minutes |
| 20 mL Arm | Total Procedure Time | 5.7 minutes |