Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532162
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The PRICE Trial Pain Reduction for Intrauterine Contraception Experiment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The PRICE Trial Pain Reduction for Intrauterine Contraception Experiment a Double-blind Triple Arm Randomized Controlled Trial of 1 Lidocaine Paracervical Block for IUD Insertion
Status:
COMPLETED
Status Verified Date:
2024-10
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:
PRICE
Brief Summary:
Intrauterine devices IUDs are a highly effective form of reversible contraception with a less than 1 failure rate They can be easily placed in the office and require little maintenance care However despite their benefits pain during insertion remains a barrier for patient uptake Currently there is no standard of care for pain management during IUD insertion The aim of this study is to determine whether local anesthetic in the form of injecting 1 percent lidocaine into the cervicovaginal junction reduces pain during insertion Participants will be randomly assigned to receive 1 percent lidocaine placebo or no injection All patients presenting for IUD placement regardless of indication will be offered participation in the study Following IUD placement patients will be asked to rate their pain at key pain points during the procedure as the primary outcome Other outcomes collected will include provider-related complications length of time to place IUD and overall patient and provider satisfaction
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