Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05972681
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-07-17
Brief Title:
The PAIN Pelvic Area Injection for Numbness Study
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Randomized Controlled Trial of Bupivacaine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia
Status:
RECRUITING
Status Verified Date:
2024-09
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 prevalence of perineal lacerations is more than 75 of all vaginal deliveries The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 711 Once the analgesic effect of the epidural analgesia fades the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period extend hospital stays and increase the potential for serious adverse reactions with pain medications
The research hypothesis of this study is that adding a locally injected analgesic which will take effect once the epidural analgesia fades may alleviate perineal pain and improve womens overall well-being and satisfaction
This is a superiority two-arm quadruple-blinded prospective randomized controlled trial with the objective to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair Women with a working epidural analgesia and status post a vaginal delivery involving a second-degree laceration will be invited to participate Women in the local anesthesia LA arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline The differences in perineal pain between the groups will be evaluated at time of the first analgesic TFA demand maternal satisfaction at 24 hours and visual analog scale VAS pain score
The research hypothesis of this study is that adding a locally injected analgesic which will take effect once the epidural analgesia fades may alleviate perineal pain and improve womens overall well-being and satisfaction
This is a superiority two-arm quadruple-blinded prospective randomized controlled trial with the objective to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair Women with a working epidural analgesia and status post a vaginal delivery involving a second-degree laceration will be invited to participate Women in the local anesthesia LA arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline The differences in perineal pain between the groups will be evaluated at time of the first analgesic TFA demand maternal satisfaction at 24 hours and visual analog scale VAS pain score
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None