EXPAREL® for Pain After Tonsillectomy

• 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: Mayo Clinic
• Information provided by (Responsible Party): Daniel L. Price, M.D., Mayo Clinic

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Daniel L Price, MD; Mayo Clinic

More Information

• Responsible Party: Daniel L. Price, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02444533
• Other Study ID Numbers: 14-007071
• First Posted: May 14, 2015
• 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

• 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:

Tonsillitis; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents