An interventional study of Paracervical Block with lidocaine and Sham paracervical block in Pain, sponsored by University of Hawaii. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-14.
Sponsored by University of Hawaii · Not applicable, Interventional, and Treatment
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
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.
University of Hawaii is the lead sponsor of 95 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Drug: Paracervical Block with lidocaine
A sham block will be done prior to the placement of laminaria using a capped needle
Drug: Sham paracervical block
Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
Also known as: Paracervical block
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
Also known as: Sham block; placebo
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
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
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
Participants recruited from May 2015 to Dec 2015 at two of the faculty practice offices of the University of Hawaii Department of OB/gyn.
| Milestone | Paracervical Block With Lidocaine | Sham Paracervical Block |
|---|---|---|
| Started | 20 | 21 |
| Completed | 20 | 21 |
| Not completed | 0 | 0 |
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.
| units on a scale (100 mm VAS) | Paracervical Block With Lidocaine | Sham Paracervical Block |
|---|---|---|
| Pain After Placement of Laminaria (100 mm Visual Analog Scale) | 13 (2 to 39) | 54 (27 to 61) |
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
| units on a scale (100 mm VAS) | Paracervical Block Group | Sham Block Group |
|---|---|---|
| Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | 95 (78 to 100) | 70 (44 to 90) |
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.
| units on a scale (100 mm VAS) | Paracervical Block Group | Sham Block Group |
|---|---|---|
| Paracervical or Sham Block Pain | 14 (6 to 31) | 27 (6 to 41) |
Collected over 7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paracervical Block With Lidocaine | — | 0/20 (0%) | 0/20 (0%) |
| Sham Paracervical Block | — | 0/21 (0%) | 0/21 (0%) |
| Age, Continuous(years) | Paracervical Block Group | Sham Block Group | Total |
|---|---|---|---|
| Mean | 25.80 ± 6.12 | 29.81 ± 6.92 | 27.85 ± 6.77 |
| Sex/Gender, Customized(Participants) | Paracervical Block Group | Sham Block Group | Total |
|---|---|---|---|
| Females | 20 | 21 | 41 |
| Race/Ethnicity, Customized(Participants) | Paracervical Block Group | Sham Block Group | Total |
|---|---|---|---|
| White/Caucasian | 5 | 7 | 12 |
| Black/African American | 1 | 0 | 1 |
| Asian | 5 | 9 | 14 |
| Native Hawaiian/Pacific Islander | 10 | 10 | 20 |
| Hispanic/Latina | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Paracervical Block Group | Sham Block Group | Total |
|---|---|---|---|
| United States | 20 | 21 | 41 |
Plan to share: No
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Hawaii