Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
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ClinicalTrials.gov Identifier: NCT04000191 |
Recruitment Status :
Withdrawn
(Study was neer started and PI left the institution.)
First Posted : June 27, 2019
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Anesthesia, Local | Procedure: MAC Other: Perianal ice application | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 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 : | October 2020 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | April 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.
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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.
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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. |
- 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)
- 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 |
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

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
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
Principal Investigator: | Uma R Phatak, MD MS | Boston Medical Center |
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: | October 8, 2020 |
Last Verified: | October 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 |
ice elective anorectal surgery anesthesia care |