Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

NCT04000191 | Withdrawn

• 1 other identifier: H-38798
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local

Keywords

ice; elective anorectal surgery; anesthesia care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant self pain assessment in the recovery area

  Within 2 hours after each surgical procedure

Study Arms (2)

Usual monitored anesthesia care (MAC)

ACTIVE COMPARATOR

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

Procedure: MAC

MAC and perianal ice

EXPERIMENTAL

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; Other: Perianal ice application

Interventions

MAC 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; Usual monitored anesthesia care (MAC)

Perianal ice application OTHER

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

MAC and perianal ice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Uma R Phatak, MD MS

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 27, 2019
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)