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Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000191
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

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.

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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

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.




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).



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000191


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

Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
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Principal Investigator: Uma R Phatak, MD MS Boston Medical Center

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT04000191    
Other Study ID Numbers: H-38798
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs