TonsillectomyPhase 4NCT02444533
EXPAREL® for Pain After Tonsillectomy
A Phase 4 study testing Liposomal Bupivacaine in people with Tonsillectomy and Tonsillitis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tonsillectomy, Tonsillitis, Post-operative Pain
- What is being tested?
- Liposomal Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
- Willing and able to understand and provide written informed consent
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
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.
Read the 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.
- Conditions
- Tonsillectomy, Tonsillitis, Post-operative Pain
- Being tested
- Liposomal Bupivacaine
- Keywords
- Liposomal Bupivacaine
- Medical subject headings
- Tonsillitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy Receives: Drug: Liposomal Bupivacaine |
| No treatment | No intervention | Patient will not be given any medications in the tonsillar fossae after tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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
Measured: 2 weeks after surgery
Oral Intake (Patient Recorded Oral Intake)
Subjects recorded oral intake over one week after surgery
Measured: 1 week after surgery
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TonsillectomyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel L. Price, M.D., Mayo Clinic
- Investigators
- Daniel L Price, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444533
- Sponsor's protocol ID
- 14-007071
- Status last verified
- Jun 2017
- First submitted
- 8 May 2015
- Last updated
- 14 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients
- ClinicalTrials.gov ID
- NCT02444533
- Acronym / sponsor ID
- 14-007071
- Conditions
- Tonsillectomy, Tonsillitis, Post-operative Pain
- Keywords
- Liposomal Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Drug: Liposomal BupivacainePatient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy |
| No treatment | No intervention | –Patient will not be given any medications in the tonsillar fossae after tonsillectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
- Willing and able to understand and provide written informed consent
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal BupivacaineAlso: ExparelInjection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy. | Drug | Liposomal Bupivacaine |
Primary outcome
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"
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
Oral Intake (Patient Recorded Oral Intake)
Time frame: 1 week after surgery
Subjects recorded oral intake over one week after surgery
2 secondary outcomes
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)
Time frame: 4 weeks
Number of Subjects With Post-tonsillectomy Bleeding
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel L Price, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivacaine in people with Tonsillectomy and Tonsillitis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (Pain Scores on a 0/10 Scale) (time frame: day of surgery, 14 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.