Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual monitored anesthesia care (MAC)

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

Group Type ACTIVE_COMPARATOR

MAC

Intervention Type PROCEDURE

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.

MAC and perianal ice

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.

Group Type EXPERIMENTAL

MAC

Intervention Type PROCEDURE

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.

Perianal ice application

Intervention Type OTHER

Application of ice to the perianal area after the area is prepared with betadine, prior to injection of local anesthesia by the surgeon.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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