Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546254
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
1 Lidocaine Paracervical Block for Endometrial Biopsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Triple-arm Randomized Controlled Trial of 1 Lidocaine Paracervical Block for Endometrial Biopsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine whether 1 lidocaine paracervical block reduces pain during endometrial biopsy in comparison to sham paracervical injection with normal saline or no intervention
The proposed study is a double-blind triple arm placebo-controlled randomized controlled trial RCT Each participant will be randomly assigned to one of three arms
1 intervention paracervical block - 10 cc 1 lidocaine with epinephrine
2 placebo 10 cc paracervical injection of normal saline
3 control gently tapping the cervicovaginal junction with a capped needle
The primary outcome will be a global pain score which will be patient-reported by the 100 mm Visual Analogue Scale VAS following the procedure
The proposed study is a double-blind triple arm placebo-controlled randomized controlled trial RCT Each participant will be randomly assigned to one of three arms
1 intervention paracervical block - 10 cc 1 lidocaine with epinephrine
2 placebo 10 cc paracervical injection of normal saline
3 control gently tapping the cervicovaginal junction with a capped needle
The primary outcome will be a global pain score which will be patient-reported by the 100 mm Visual Analogue Scale VAS following the procedure
Detailed Description:
None
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