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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Active Comparator | Patient 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Number of Subjects With Post-tonsillectomy Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel L Price, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy. |
| FG001 | No Treatment | Patient will not be given any medications in the tonsillar fossae after tonsillectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographics include only subjects who were reported as having at least partial outcome data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy. |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | Results include only subjects who were reported as having at least partial outcome data. | Posted | Mean | Standard Deviation | units on a scale | day of surgery, 14 days after surgery |
|
5 weeks post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy. Liposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Price | Mayo Clinic | 507-293-4395 | Price.Daniel@mayo.edu |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection. |
| 4 weeks |
Patient will not be given any medications in the tonsillar fossae after tonsillectomy |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patient will not be given any medications in the tonsillar fossae after tonsillectomy
|
|
|
| Primary | Pain Medication Usage (Milligrams Used) | Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame | One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17. | Posted | Mean | Standard Deviation | mg | 2 weeks after surgery |
|
|
|
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| Primary | Oral Intake (Patient Recorded Oral Intake) | Subjects recorded oral intake over one week after surgery | Posted | Mean | Standard Deviation | mL | 1 week after surgery |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | 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. | In the Liposomal Bupivacaine arm, 15 subjects had data on the primary endpoints, and an additional 2 provided information regarding post-procedure complications, but didn't provide data on other outcomes, therefore the analysis population for the Liposomal Bupivacaine is 17. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | No Treatment | Patient will not be given any medications in the tonsillar fossae after tonsillectomy | 0 | 22 | 0 | 22 | 0 | 22 |
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Oxycodone (OxyContin) |
|
| t-test, 2 sided |
| 0.970 |
| Superiority |
| Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05. | t-test, 2 sided | 0.835 | Superiority |
| Hospital admission related to the study drug |
|
| No bleeding |
|