EXPAREL® for Pain After Tonsillectomy
Primary Purpose
Tonsillectomy, Tonsillitis, Post-operative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillectomy focused on measuring Liposomal Bupivacaine
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
- Willing and able to understand and provide written informed consent
Exclusion Criteria:
- Known pregnancy
- Women who are currently nursing a child
- History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder
- Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation
- Inability to provide informed consent (patients under guardianship)
- Known hypersensitivity to local anesthetics
- History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
- History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.
- Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.
- History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Liposomal Bupivacaine
No treatment
Arm Description
Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Outcomes
Primary Outcome Measures
Pain Score (Pain Scores on a 0/10 Scale)
Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"
Pain Medication Usage (Milligrams Used)
Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame
Oral Intake (Patient Recorded Oral Intake)
Subjects recorded oral intake over one week after surgery
Secondary Outcome Measures
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)
Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.
Number of Subjects With Post-tonsillectomy Bleeding
The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02444533
Brief Title
EXPAREL® for Pain After Tonsillectomy
Official Title
A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.
Detailed Description
Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.
There will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy, Tonsillitis, Post-operative Pain
Keywords
Liposomal Bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Active Comparator
Arm Description
Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Primary Outcome Measure Information:
Title
Pain Score (Pain Scores on a 0/10 Scale)
Description
Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"
Time Frame
day of surgery, 14 days after surgery
Title
Pain Medication Usage (Milligrams Used)
Description
Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame
Time Frame
2 weeks after surgery
Title
Oral Intake (Patient Recorded Oral Intake)
Description
Subjects recorded oral intake over one week after surgery
Time Frame
1 week after surgery
Secondary Outcome Measure Information:
Title
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)
Description
Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.
Time Frame
4 weeks
Title
Number of Subjects With Post-tonsillectomy Bleeding
Description
The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
Willing and able to understand and provide written informed consent
Exclusion Criteria:
Known pregnancy
Women who are currently nursing a child
History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder
Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation
Inability to provide informed consent (patients under guardianship)
Known hypersensitivity to local anesthetics
History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.
Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.
History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel L Price, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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EXPAREL® for Pain After Tonsillectomy
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