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Clinical Trials/NCT04000191
NCT04000191
Withdrawn
Not Applicable

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

Boston Medical Center1 site in 1 countryOctober 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Boston Medical Center
Locations
1
Primary Endpoint
Amount of drugs administered to each participant
Status
Withdrawn
Last Updated
5 years ago

Overview

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, 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.

Registry
clinicaltrials.gov
Start Date
October 2020
End Date
April 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Amount of drugs administered to each participant

Time Frame: Within 1 days after each surgical procedure

The total number of milligrams for each medication administered by the anesthesiologist will be recorded (eg Versed, Fentanyl, Propofol, etc)

Secondary Outcomes

  • Participant self pain assessment in the recovery area(Within 2 hours after each surgical procedure)

Study Sites (1)

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