Anesthesia, LocalNCT04000191
Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
A study testing MAC and Perianal ice application in people with Anesthesia, Local, run by Boston Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- MAC and Perianal ice application
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patient with planned minor elective colorectal surgery (eg for hemorrhoids, perianal abscess, fistula in ano, anal fissure, pilonidal cysts, or anal condyloma)
Who cannot join
- -Patient who requires general anesthesia as part of the initial anesthesia plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Numb the Bum: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
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.
Read the 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.
- Conditions
- Anesthesia, Local
- Being tested
- MAC, Perianal ice application
- Keywords
- ice, elective anorectal surgery, anesthesia care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACProcedure or surgery
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.
Perianal ice applicationOther
Application of ice to the perianal area after the area is prepared with betadine, prior to injection of local anesthesia by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Usual monitored anesthesia care (MAC) | Active comparator | Monitored anesthesia care (MAC) administered by anesthesiology and injection of local anesthesia by the operating surgeon. Receives: 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. Receives: Procedure: MAC; Other: Perianal ice application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 1 days after each surgical procedure
Secondary outcomes (1)
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).
Measured: Within 2 hours after each surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study startOct 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: Study was neer started and PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uma R Phatak, MD MS, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000191
- Sponsor's protocol ID
- H-38798
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Numb the Bum: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
- ClinicalTrials.gov ID
- NCT04000191
- Acronym / sponsor ID
- H-38798
- Conditions
- Anesthesia, Local
- Keywords
- ice, elective anorectal surgery, anesthesia care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was neer started and PI left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual monitored anesthesia care (MAC) | Active comparator | Procedure: MACMonitored anesthesia care (MAC) administered by anesthesiology and injection of local anesthesia by the operating surgeon. |
| MAC and perianal ice | Experimental | Procedure: MAC, Other: Perianal ice applicationMonitored 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patient with planned minor elective colorectal surgery (eg for hemorrhoids, perianal abscess, fistula in ano, anal fissure, pilonidal cysts, or anal condyloma)
Key exclusion criteria (1 listed)
- -Patient who requires general anesthesia as part of the initial anesthesia plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MACMonitored 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. | Procedure or surgery | MAC and perianal ice, Usual monitored anesthesia care (MAC) |
| Perianal ice applicationApplication of ice to the perianal area after the area is prepared with betadine, prior to injection of local anesthesia by the surgeon. | Other | MAC and perianal ice |
Primary outcome
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)
1 secondary outcome
Participant self pain assessment in the recovery area
Time frame: Within 2 hours after each surgical procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma R Phatak, MD MS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAC and Perianal ice application in people with Anesthesia, Local, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of drugs administered to each participant (time frame: Within 1 days after each surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.