Ignite Creation Date:
2024-05-05 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00613821
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2008-01-31
Brief Title:
Lidocaine and Pain Management in First Trimester Abortions
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
A Comparison of Intrauterine Lidocaine Infusion and Paracervical Block for Pain Management in First Trimester Abortions
Status:
COMPLETED
Status Verified Date:
2017-07
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:
The purpose of this study is to examine the effect of lidocaine a numbing medication inside the uterus on patient pain during an early abortion compared to the paracervical block lidocaine injected on either side of the cervix
Detailed Description:
The Investigators intend to conduct a randomized patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette Women will be approached about this study after they have made a decision to terminate the pregnancy The women will be blinded and randomized into one of two study arms
Group 1 the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 oclock This will approximate the steps involved in a paracervical block without injecting the patient Following this the patient will receive a 5 milliliter intrauterine infusion of 4 lidocaine using a sterile 3mm Novak curette The infusion will be placed slowly over 3 minutes
Group 2 a standard paracervical block 8 milliliter 1 lidocaine at 4 and 8 oclock at the cervical-vaginal reflection will be placed Following this a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes The curette will not be placed through the cervix and no infusion will be performed This will approximate the steps involved in an intrauterine infusion without injecting the patient
During the procedure women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale VAS
Group 1 the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 oclock This will approximate the steps involved in a paracervical block without injecting the patient Following this the patient will receive a 5 milliliter intrauterine infusion of 4 lidocaine using a sterile 3mm Novak curette The infusion will be placed slowly over 3 minutes
Group 2 a standard paracervical block 8 milliliter 1 lidocaine at 4 and 8 oclock at the cervical-vaginal reflection will be placed Following this a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes The curette will not be placed through the cervix and no infusion will be performed This will approximate the steps involved in an intrauterine infusion without injecting the patient
During the procedure women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale VAS
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