Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Anesthesia, Local

Treatments: Procedure: MAC; Other: Perianal ice application

Study type: Interventional

Funder types: Other

Identifiers

NCT04000191

H-38798

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Patient with planned minor elective colorectal surgery (eg for hemorrhoids, perianal abscess, fistula in ano, anal fissure, pilonidal cysts, or anal condyloma)

Exclusion criteria

-Patient who requires general anesthesia as part of the initial anesthesia plan

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Usual monitored anesthesia care (MAC)

Active Comparator group

Description:

Monitored anesthesia care (MAC) administered by anesthesiology and injection of local anesthesia by the operating surgeon.

Treatment:

Procedure: MAC

MAC and perianal ice

Experimental group

Description:

Monitored anesthesia care (MAC) administered by anesthesiology, application of ice to the perianal area after it is prepared with betadine, and injection of local anesthesia by the operating surgeon.

Treatment:

Procedure: MAC

Other: Perianal ice application