Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02354092
Status:
TERMINATED
Last Update Posted:
2019-06-11
First Post:
2015-01-29
Brief Title:
Paracervical Block for Pain Control With Osmotic Dilator Placement
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Paracervical Block for Pain Control During Osmotic Dilator Placement a Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cervical dilators are frequently used for preparation prior to second trimester surgical abortion While their use decreases complications associated with surgical abortion their placement is often uncomfortable for the patient Currently there are no proven methods for reducing pain during osmotic dilator placement The use of numbing medication around the cervix paracervical block may decrease this placement pain
Detailed Description:
It is estimated that 121 million abortions were performed in 2008 Of these approximately 11 occurred in the second trimester and 14 occurred after 21 weeks gestation In the United States dilation and evacuation DE is the most common method of terminating a second trimester pregnancy with greater than 98 of second trimester abortions occurring by DE
Pre-procedure cervical preparation decreases the incidence of complications associated with DE Cervical dilators are often used prior to second trimester DEs to aid in softening and dilating the cervix Typically dilator placement occurs the day of the DE or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available Many women experience moderate to severe discomfort with osmotic dilator insertion Providers use various methods to minimize this discomfort including paracervical block PCB non-steroidal anti-inflammatory medications NSAIDs anxiolytics and narcotics In particular PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose There is however no data to support their efficacy in ameliorating the pain of dilator insertion
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures The PCB is thought to work primarily by blocking pain conduction via Frankenhausers plexus As such their effect may be most important in relieving the pain associated with cervical dilation In a recent randomized control trial PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration Since osmotic dilator placement primarily involves cervical manipulation and dilation PCB may provide some pain relief over placebo The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement This trial will also provide information about the degree of pain that women experience during osmotic dilator placement information not previously known
Pre-procedure cervical preparation decreases the incidence of complications associated with DE Cervical dilators are often used prior to second trimester DEs to aid in softening and dilating the cervix Typically dilator placement occurs the day of the DE or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available Many women experience moderate to severe discomfort with osmotic dilator insertion Providers use various methods to minimize this discomfort including paracervical block PCB non-steroidal anti-inflammatory medications NSAIDs anxiolytics and narcotics In particular PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose There is however no data to support their efficacy in ameliorating the pain of dilator insertion
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures The PCB is thought to work primarily by blocking pain conduction via Frankenhausers plexus As such their effect may be most important in relieving the pain associated with cervical dilation In a recent randomized control trial PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration Since osmotic dilator placement primarily involves cervical manipulation and dilation PCB may provide some pain relief over placebo The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement This trial will also provide information about the degree of pain that women experience during osmotic dilator placement information not previously known
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None