Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04000191
• Other study ID #: H-38798
• Status: Withdrawn
• Phase: N/A
• Start date: October 2020
• Est. completion date: April 2021

Study information

• Verified date: October 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of drugs administered to each participant	The total number of milligrams for each medication administered by the anesthesiologist will be recorded (eg Versed, Fentanyl, Propofol, etc)	Within 1 days after each surgical procedure
Secondary	Participant self pain assessment in the recovery area	A validated instrument that consists of a 10cm line will be used to assess post-operative discomfort. Each participant will be asked to make a mark on the line to indicate their level of pain. The left end of the line indicates a score of "No Pain" and the right end of the line indicates "Worst Pain." The location of the mark will be measured and the pain score will be a ratio of the distance of the mark measured from the "No Pain" end over the total length of the line (10cm).	Within 2 hours after each surgical procedure