EXPAREL® for Pain After Tonsillectomy

NCT02444533 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 14-007071
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Tonsillitis; Post-operative Pain

Keywords

Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (3)

• 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"

  day of surgery, 14 days after surgery

• Pain Medication Usage (Milligrams Used)

  Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame

  2 weeks after surgery

• Oral Intake (Patient Recorded Oral Intake)

  Subjects recorded oral intake over one week after surgery

  1 week after surgery

Secondary Outcomes (2)

• Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)

  4 weeks

• Number of Subjects With Post-tonsillectomy Bleeding

  4 weeks

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy

Drug: Liposomal Bupivacaine

No treatment

NO INTERVENTION

Patient will not be given any medications in the tonsillar fossae after tonsillectomy

Interventions

Liposomal Bupivacaine DRUG

Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.

Also known as: Exparel

Liposomal Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
• Willing and able to understand and provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Tonsillitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Daniel Price
• Organization: Mayo Clinic

Price.Daniel@mayo.edu

507-293-4395

Study Officials

• Daniel L Price, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 14, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)