Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain
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|ClinicalTrials.gov Identifier: NCT03797703|
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Drug: Lidocaine Hydrochloride 2% gel enema||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain|
|Actual Study Start Date :||November 26, 2018|
|Estimated Primary Completion Date :||November 26, 2020|
|Estimated Study Completion Date :||November 26, 2020|
Patients will be randomly allocated into the treatment group. The treatment group will receive a 15 mL lidocaine gel enema rectally immediately following completion of the procedure.
Drug: Lidocaine Hydrochloride 2% gel enema
Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure.
No Intervention: Control
Patients will be randomly allocated into the control group. The control group will not receive a rectal enema.
- Change in Pain following Procedure at 1 hour, 24 hours and 48 hours [ Time Frame: This information will be collected at 1 hour, 24 hours and 48 hours after the procedure. ]This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10).
- Pain Medication Needs [ Time Frame: This will be evaluated 48 hours after the procedure. ]This effect will be measured by asking the subject what pain medication was needed following the procedure and the amount taken.
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): NCT03797703
|Contact: Charles Berkelhammer, MD||(708)email@example.com|
|United States, Illinois|
|Advocate Christ Medical Center||Recruiting|
|Oak Lawn, Illinois, United States, 60453|
|Contact: Charles Berkelhammer, MD 708-499-5678 firstname.lastname@example.org|
|Principal Investigator: Charles Berkelhammer, MD|
|Sub-Investigator: Elizabeth Brindise, DO|