NCT04000191

Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

Numb the Bum: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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, perianal/perirectal 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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
PROCEDURE	MAC	Monitored anesthesia care (MAC) administered by anesthesiology and Injection of local anesthesia mixture of 1% lidocaine with epinephrine and 0.25% Marcaine by the operating surgeon.
OTHER	Perianal ice application	Application of ice to the perianal area after the area is prepared with betadine, prior to injection of local anesthesia by the surgeon.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-06-27
• Last updated: 2020-10-08

Locations

1 site across 1 country: United States