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EXPAREL® for Pain After Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02444533
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel L. Price, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Tonsillitis Post-operative Pain Drug: Liposomal Bupivacaine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: Liposomal Bupivacaine
Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy
Drug: Liposomal Bupivacaine
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Other Name: Exparel

No Intervention: No treatment
Patient will not be given any medications in the tonsillar fossae after tonsillectomy



Primary Outcome Measures :
  1. Pain Score (Pain Scores on a 0/10 Scale) [ Time Frame: day of surgery, 14 days after surgery ]
    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"

  2. Pain Medication Usage (Milligrams Used) [ Time Frame: 2 weeks after surgery ]
    Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame

  3. Oral Intake (Patient Recorded Oral Intake) [ Time Frame: 1 week after surgery ]
    Subjects recorded oral intake over one week after surgery


Secondary Outcome Measures :
  1. Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) [ Time Frame: 4 weeks ]
    Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.

  2. Number of Subjects With Post-tonsillectomy Bleeding [ Time Frame: 4 weeks ]
    The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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): NCT02444533


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Daniel L Price, MD Mayo Clinic

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Responsible Party: Daniel L. Price, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02444533     History of Changes
Other Study ID Numbers: 14-007071
First Posted: May 14, 2015    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel L. Price, M.D., Mayo Clinic:
Liposomal Bupivacaine
Additional relevant MeSH terms:
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Tonsillitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents