Pain
Conditions
Keywords
Laminaria
Brief summary
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
Detailed description
Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.
Interventions
DRUGParacervical Block with lidocaine
Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
Sponsors
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women between the ages of 18-49 years * Desiring surgical termination of pregnancy or surgical management of a fetal demise * Treatment plan involves cervical preparation with laminaria * Participant able to provide informed consent in English and willing to participate in the study
Exclusion criteria
* Unable to read/speak/understand English * Contraindications to receiving lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain After Placement of Laminaria (100 mm Visual Analog Scale) | Measured within 10 seconds after placement of laminaria | We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | 15 minutes post-operatively | Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied |
| Paracervical or Sham Block Pain | Within 10 seconds after receiving paracervical or sham block | Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. |
Countries
United States
Participant flow
Recruitment details
Participants recruited from May 2015 to Dec 2015 at two of the faculty practice offices of the University of Hawaii Department of OB/gyn.
Participants by arm
| Arm | Count |
|---|---|
| Paracervical Block Group Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria. | 20 |
| Sham Block Group Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix. | 21 |
| Total | 41 |
Baseline characteristics
| Characteristic | Paracervical Block Group | Sham Block Group | Total |
|---|---|---|---|
| Age, Continuous | 25.80 years STANDARD_DEVIATION 6.12 | 29.81 years STANDARD_DEVIATION 6.92 | 27.85 years STANDARD_DEVIATION 6.77 |
| Race/Ethnicity, Customized Asian | 5 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Black/African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized White/Caucasian | 5 Participants | 7 Participants | 12 Participants |
| Region of Enrollment United States | 20 Participants | 21 Participants | 41 Participants |
| Sex/Gender, Customized Females | 20 Participants | 21 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
Pain After Placement of Laminaria (100 mm Visual Analog Scale)
We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Time frame: Measured within 10 seconds after placement of laminaria
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracervical Block With Lidocaine | Pain After Placement of Laminaria (100 mm Visual Analog Scale) | 13 units on a scale (100 mm VAS) |
| Sham Paracervical Block | Pain After Placement of Laminaria (100 mm Visual Analog Scale) | 54 units on a scale (100 mm VAS) |
p-value: 0.01Wilcoxon (Mann-Whitney)
Secondary
Paracervical or Sham Block Pain
Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Time frame: Within 10 seconds after receiving paracervical or sham block
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracervical Block With Lidocaine | Paracervical or Sham Block Pain | 14 units on a scale (100 mm VAS) |
| Sham Paracervical Block | Paracervical or Sham Block Pain | 27 units on a scale (100 mm VAS) |
p-value: 0.34Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied
Time frame: 15 minutes post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracervical Block With Lidocaine | Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | 95 units on a scale (100 mm VAS) |
| Sham Paracervical Block | Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | 70 units on a scale (100 mm VAS) |
p-value: 0.05Wilcoxon (Mann-Whitney)