Pregnancy, Unwanted
Conditions
Keywords
abortion, pain management
Brief summary
Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial. If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.
Detailed description
Abortion remains one of the most common surgical procedures in the world, regardless of region or development status \[Guttmacher 2012\]. In the United States, at least half of all women will experience an unintended pregnancy by age 45, and one third of all women will have had an abortion by this same age \[Guttmacher 2014\]. Despite universal efforts to increase the comfort of these procedures, pain remains a limiting factor in where and how abortion is performed. Recent estimates reveal that 70-97% of women experience pain during abortion \[Renner 2010, Paul 2009, Belanger 1988\]. Strategies to reduce all aspects of abortion related pain have the potential for significant public health impact, given the large number of women who seek these services. A survey of National Abortion Federation clinics found that to date, most providers (84%) employ the use of a lidocaine paracervical block for cervical anesthesia prior to abortion \[O'Connell 2009\], but traditionally without a waiting period between lidocaine administration and procedure initiation. To the best of our knowledge, there are no published studies that 1) rigorously examine the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explore whether adequate pain relief is possible through self-administered, non-invasive means alone. The investigators propose to explore the effect of a locally applied lidocaine gel in place of the traditional paracervical block to decrease abortion related pain. The objective of this study is to compare pain control at various time points during first trimester surgical abortion using a locally applied, patient-administered lidocaine gel as compared to traditional lidocaine paracervical block. If a patient-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures, and perhaps replace paracervical injection altogether. Hypothesis: Patients who receive lidocaine gel applied 30 minutes prior to first trimester surgical abortion will have pain control equivalent to that of a traditional paracervical block. This is a non-inferiority, open-label, randomized controlled trial of women ages 18 and older undergoing first trimester surgical abortion at 50/7 to 116/7 weeks.
Interventions
DRUGvaginal 2% Xylocaine
patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block
DRUGstandard lidocaine paracervical block
1% lidocaine paracervical injection
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 ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age * Use of IV sedation for pain management * English or Spanish speaking * Ability to give informed consent
Exclusion criteria
* Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic) * Allergy to study medications: lidocaine, midazolam, fentanyl * Known uterine anomaly * Prior cervical surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale | At time of cervical dilation, 30 minutes after lidocaine administration | This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Speculum Insertion as Measured by a Visual Analog Scale | Pain at time of speculum insertion | This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable. |
| Pain With Tenaculum Placement as Measured by a Visual Analog Scale | Pain at time of tenaculum placement | This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable. |
| Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale | Pain level prior to procedure | This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable. |
| Overall Satisfaction With Procedure as Measured by a Visual Analog Scale | 30-45 minutes after completion of procedure | This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible. |
| Overall Complication Rate as Measured by a Count of Participants in Each Group | Rate of complications at the end of the study | — |
| Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale | Pain prior to discharge home: 30-45 minutes after completion of procedure | This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator Drug: vaginal 2% Xylocaine
vaginal 2% Xylocaine: patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block | 69 |
| Standard Lidocaine Paracervical Block standard lidocaine paracervical block
standard lidocaine paracervical block: 1% lidocaine paracervical injection | 68 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Active Comparator | Standard 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 | 69 Participants | 68 Participants | 137 Participants |
| Sex: Female, Male Female | 69 Participants | 68 Participants | 137 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 | — / — | — / — |
| other Total, other adverse events | 0 / 69 | 0 / 68 |
| serious Total, serious adverse events | 0 / 69 | 0 / 68 |
Outcome results
Primary
Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Time frame: At time of cervical dilation, 30 minutes after lidocaine administration
Population: Treated participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator | Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale | 68 units on a scale |
| Standard Lidocaine Paracervical Block | Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale | 65 units on a scale |
Secondary
Overall Complication Rate as Measured by a Count of Participants in Each Group
Time frame: Rate of complications at the end of the study
Population: All treated patients were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator | Overall Complication Rate as Measured by a Count of Participants in Each Group | 0 Participants |
| Standard Lidocaine Paracervical Block | Overall Complication Rate as Measured by a Count of Participants in Each Group | 0 Participants |
Secondary
Overall Satisfaction With Procedure as Measured by a Visual Analog Scale
This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.
Time frame: 30-45 minutes after completion of procedure
Population: All treated patients were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator | Overall Satisfaction With Procedure as Measured by a Visual Analog Scale | 86 units on a scale |
| Standard Lidocaine Paracervical Block | Overall Satisfaction With Procedure as Measured by a Visual Analog Scale | 92.5 units on a scale |
Secondary
Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Time frame: Pain prior to discharge home: 30-45 minutes after completion of procedure
Population: All treated patients were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator | Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale | 9 units on a scale |
| Standard Lidocaine Paracervical Block | Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale | 11.5 units on a scale |
Secondary
Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Time frame: Pain level prior to procedure
Population: Treated patients were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Comparator | Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale | 59 units on a scale |
| Standard Lidocaine Paracervical Block | Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale | 56 units on a scale |
Secondary
Pain With Speculum Insertion as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Time frame: Pain at time of speculum insertion
Population: Treated patients were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator | Pain With Speculum Insertion as Measured by a Visual Analog Scale | 19.5 units on a scale | Standard Deviation 18.4 |
| Standard Lidocaine Paracervical Block | Pain With Speculum Insertion as Measured by a Visual Analog Scale | 22.3 units on a scale | Standard Deviation 19.5 |
Secondary
Pain With Tenaculum Placement as Measured by a Visual Analog Scale
This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.
Time frame: Pain at time of tenaculum placement
Population: All treated patients were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Comparator | Pain With Tenaculum Placement as Measured by a Visual Analog Scale | 39.8 units on a scale | Standard Deviation 22.3 |
| Standard Lidocaine Paracervical Block | Pain With Tenaculum Placement as Measured by a Visual Analog Scale | 32.4 units on a scale | Standard Deviation 24.3 |