Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04000191
Status:
WITHDRAWN
Last Update Posted:
2020-10-08
First Post:
2019-06-17
Brief Title:
Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Numb the Bum Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was neer started and PI left the institution
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 determine among patients receiving elective anorectal surgery does application of ice to the perianal area prior to the procedure lead to use of decreased amounts of intravenous IV anesthesia Anorectal surgeries for hemorrhoids fistulas and fissures are done on an outpatient basis under monitored anesthesia care This means patients get sedating medications through an IV but often do not require intubation The difficulty with monitored anesthesia is balancing patient comfort against the risk of apnea not breathing due to over sedation Application of ice to the perianal area may help increase patient comfort decrease the amounts of medications given for sedation and therefore decrease risk and increase recovery from the anesthesia
Detailed Description:
The study design will be a randomized control trial of adults undergoing elective surgery for hemorrhoids fistulas perianalperirectal abscess and anal fissure Participants will be randomized in a 1 to 1 ratio using a random number generator to two arms to the study - usual care vs usual care plus ice to numb the anal area prior to incision
The outcomes will be measured the same day as the surgery Prior to leaving the operating room the anesthesia team will share with the surgeon the amount of each drug they administered A comfort score will be recorded by the study personnel in the recovery area prior to discharge for each participant
The outcomes will be measured the same day as the surgery Prior to leaving the operating room the anesthesia team will share with the surgeon the amount of each drug they administered A comfort score will be recorded by the study personnel in the recovery area prior to discharge for each participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None