Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

• ClinicalTrials.gov Identifier: NCT04000191
• Recruitment Status: Not yet recruiting
• First Posted: June 27, 2019
• Last Update Posted: March 25, 2020
• Sponsor: Boston Medical Center
• Information provided by (Responsible Party): Boston Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia, Local	Procedure: MAC; Other: Perianal ice application	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Numb the Bum: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
• Estimated Study Start Date: May 2020
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual monitored anesthesia care (MAC); Monitored anesthesia care (MAC) administered by anesthesiology and injection of local anesthesia by the operating surgeon.	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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Participant self pain assessment in the recovery area [ Time Frame: Within 2 hours after each surgical procedure ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Uma R Phatak, MD MS; 617-414-8063; uma.phatak@bmc.org

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

Investigators

• Principal Investigator: Uma R Phatak, MD MS; Boston Medical Center

More Information

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT04000191
• Other Study ID Numbers: H-38798
• First Posted: June 27, 2019
• Last Update Posted: March 25, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Medical Center:

ice; elective anorectal surgery; anesthesia care

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs