Post-operative Pain, Tonsillectomy, Tonsillitis
Conditions
Keywords
Liposomal Bupivacaine
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.
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.
Interventions
DRUGLiposomal Bupivacaine
Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (Pain Scores on a 0/10 Scale) | 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) | 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) | 1 week after surgery | Subjects recorded oral intake over one week after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | 4 weeks | Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug. |
| Number of Subjects With Post-tonsillectomy Bleeding | 4 weeks | The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| No Treatment Patient will not be given any medications in the tonsillar fossae after tonsillectomy | 18 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not able to complete forms | 0 | 2 |
| Overall Study | Only gave post-procedure complications | 2 | 2 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | No Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 18 Participants | 33 Participants |
| Region of Enrollment United States | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 22 |
| other Total, other adverse events | 0 / 17 | 0 / 22 |
| serious Total, serious adverse events | 0 / 17 | 0 / 22 |
Outcome results
Primary
Oral Intake (Patient Recorded Oral Intake)
Subjects recorded oral intake over one week after surgery
Time frame: 1 week after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Oral Intake (Patient Recorded Oral Intake) | 13715 mL | Standard Deviation 7551 |
| No Treatment | Oral Intake (Patient Recorded Oral Intake) | 12492 mL | Standard Deviation 4271 |
Comparison: Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.p-value: 1t-test, 2 sided
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
Time frame: 2 weeks after surgery
Population: One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Pain Medication Usage (Milligrams Used) | Ibuprofen (Motrin) | 14013 mg | Standard Deviation 18109 |
| Liposomal Bupivacaine | Pain Medication Usage (Milligrams Used) | Acetaminophen (Tylenol) | 30615 mg | Standard Deviation 13196 |
| Liposomal Bupivacaine | Pain Medication Usage (Milligrams Used) | Oxycodone (OxyContin) | 265 mg | Standard Deviation 246 |
| No Treatment | Pain Medication Usage (Milligrams Used) | Ibuprofen (Motrin) | 9753 mg | Standard Deviation 11509 |
| No Treatment | Pain Medication Usage (Milligrams Used) | Acetaminophen (Tylenol) | 31287 mg | Standard Deviation 13185 |
| No Treatment | Pain Medication Usage (Milligrams Used) | Oxycodone (OxyContin) | 244 mg | Standard Deviation 159 |
Comparison: Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.p-value: 0.65t-test, 2 sided
Comparison: Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.p-value: 0.97t-test, 2 sided
Comparison: Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.p-value: 0.835t-test, 2 sided
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
Time frame: day of surgery, 14 days after surgery
Population: Results include only subjects who were reported as having at least partial outcome data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine | Pain Score (Pain Scores on a 0/10 Scale) | day of surgery | 3.07 units on a scale | Standard Deviation 2.03 |
| Liposomal Bupivacaine | Pain Score (Pain Scores on a 0/10 Scale) | 14 days after surgery | 1.76 units on a scale | Standard Deviation 1.44 |
| No Treatment | Pain Score (Pain Scores on a 0/10 Scale) | day of surgery | 4.9 units on a scale | Standard Deviation 2.79 |
| No Treatment | Pain Score (Pain Scores on a 0/10 Scale) | 14 days after surgery | 1.42 units on a scale | Standard Deviation 1.04 |
Comparison: Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.p-value: 0.043t-test, 2 sided
Comparison: Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.p-value: 0.445t-test, 2 sided
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Allergic reaction | 0 Participants |
| Liposomal Bupivacaine | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Swallowing dysfunction | 0 Participants |
| Liposomal Bupivacaine | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Hospital admission related to the study drug | 0 Participants |
| No Treatment | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Allergic reaction | 0 Participants |
| No Treatment | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Swallowing dysfunction | 0 Participants |
| No Treatment | Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) | Hospital admission related to the study drug | 0 Participants |
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine | Number of Subjects With Post-tonsillectomy Bleeding | Any form of bleeding | 4 Participants |
| Liposomal Bupivacaine | Number of Subjects With Post-tonsillectomy Bleeding | Required a trip back to the operating room | 2 Participants |
| Liposomal Bupivacaine | Number of Subjects With Post-tonsillectomy Bleeding | No bleeding | 11 Participants |
| No Treatment | Number of Subjects With Post-tonsillectomy Bleeding | Any form of bleeding | 2 Participants |
| No Treatment | Number of Subjects With Post-tonsillectomy Bleeding | Required a trip back to the operating room | 1 Participants |
| No Treatment | Number of Subjects With Post-tonsillectomy Bleeding | No bleeding | 15 Participants |