Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03797703 |
| Other study ID # |
AHC-6999-M5000223 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2018 |
| Est. completion date |
June 5, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Advocate Health Care |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema
(Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation
of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study.
During the endoscopic band ligation procedure, patients will be blindly placed into the
treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel
immediately upon cessation of the procedure. In the placebo arm, oral pain medications will
be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48
hours via telephone call. Another telephone call will be performed at 72 to 96 hours to
assess any side effects of the medication.
Description:
This is a prospective single center study to evaluate side effects and efficacy of a
lidocaine jelly 2% enema following endoscopic hemorrhoid band ligation. The investigators
will administer a single dose of 15 mL lidocaine jelly 2%, obtained from Advocate main
pharmacy, as an enema immediately post procedure. Patients will not be permitted to
self-administer additional doses following discharge.
Prior to being enrolled in the study, the clinician will perform a Comprehensive Metabolic
Panel and Complete Blood Count. When appropriate, a urine pregnancy test will be performed
prior to enrollment. The investigators will assess for any signs or symptoms of liver
disease. These assessments will occur within one month of the procedure date. If the patient
has any signs of renal or hepatic impairment (creatinine greater than 2 or Childs Pugh Class
3), they will be excluded from the study. The researchers will also exclude patients with any
history of arrhythmias or who are currently on anti-arrhythmic medications. Once the patient
is deemed safe to proceed, the lidocaine gel enema will be placed at the cessation of the
procedure by the investigator. At the time of the procedure, the clinician will assess and
use their best judgement to determine if the rectal mucosa is generally intact by visual
inspection. If the mucosa remains intact, the subject will be able to be included in the
study. However, if the rectal mucosa is traumatized the subject will be excluded and will not
participate in the randomized treatment.
Following the procedure, the patient will be monitored closely with a one-on one registered
nurse for 4 hours in an observation unit. Vital signs will be taken every 5 minutes, as well
as continuous EKG monitoring and pulse oximetry monitoring. If any adverse side effects
occur, the physician is immediately available for further management and admission to the
hospital if needed. Upon completion of the 4-hour observation period, the participants will
be evaluated by a registered nurse and physician prior to discharge home following the
procedure. The patient will be discharged with a responsible adult who will care for the
patient for 24 additional hours. The clinician will communicate with the patient and
responsible adult regarding any adverse side effects. The patient will also receive a phone
number to call to reach the physician or the physician's associate who will be able to
verbally assist the patient immediately should any adverse events occur.
For data collection, one hour following the procedure a clinician will screen for any adverse
side effects and pain will be assessed using a numeric pain scale (0-10). The patient will
also be contacted via telephone to assess adverse side effects and pain scale at 24 hours and
48 hours post procedure. The investigators will also call the patient at 72 to 96 hours to
assess for any adverse effects. The patients will be followed up by the principal
investigator for routine check-ups following the procedure. The clinician will be easily
accessible via telephone and the patient will be given instructions on how to contact the
clinician, if needed.
Data to be collected on each subject will include: date of procedure, specific patient ID,
gender, age, internal hemorrhoids grade, race (White, African American, Hispanic, Asian),
BMI, comorbid conditions, pain 1 hour post procedure, pain 24 and 48 hours post procedure,
requirement of narcotic pain medication, requirement of other oral analgesic medication,
sedation utilized and complications or adverse side effects from the medication.
Upon data collection of this trial, we will monitor for any adverse events. If there is an
adverse event that is deemed by the principal investigator likely due to drug administration,
we will report it to the FDA immediately through written communication and an IND Safety
Report. It will be reported within at least 7 calendar days of being notified of the adverse
event.
