Phase 4
N=39
EXPAREL® for Pain After Tonsillectomy
Tonsillectomy · Tonsillitis · Post-operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02444533 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Pain Score (Pain Scores on a 0/10 Scale) — 3.07; 4.9; 1.76; 1.42 units on a scale — p=0.043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score (Pain Scores on a 0/10 Scale) |
3.07; 4.9; 1.76; 1.42 | 0.043 sig |
| PRIMARY Pain Medication Usage (Milligrams Used) |
14013; 9753; 30615; 31287; 265; 244 | 0.650 |
| PRIMARY Oral Intake (Patient Recorded Oral Intake) |
13715; 12492 | 1.0 |
| SECONDARY Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Post-tonsillectomy Bleeding |
4; 2; 2; 1; 11; 15 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02444533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.