Trial Outcomes & Findings for EXPAREL® for Pain After Tonsillectomy (NCT NCT02444533)

Results Overview

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"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

39 participants

Primary outcome timeframe

day of surgery, 14 days after surgery

Results posted on

2017-07-14

Participant Flow

Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	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.	No Treatment Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Overall Study STARTED	17	22
Overall Study COMPLETED	15	18
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	No Treatment Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Overall Study Not able to complete forms	0	2
Overall Study Only gave post-procedure complications	2	2

Baseline Characteristics

EXPAREL® for Pain After Tonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Bupivacaine n=15 Participants 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.	No Treatment n=18 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: day of surgery, 14 days after surgery

Population: Results include only subjects who were reported as having at least partial outcome data.

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"

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=15 Participants 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.	No Treatment n=18 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Pain Score (Pain Scores on a 0/10 Scale) day of surgery	3.07 units on a scale Standard Deviation 2.03	4.9 units on a scale Standard Deviation 2.79
Pain Score (Pain Scores on a 0/10 Scale) 14 days after surgery	1.76 units on a scale Standard Deviation 1.44	1.42 units on a scale Standard Deviation 1.04

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=15 Participants 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.	No Treatment n=17 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Pain Medication Usage (Milligrams Used) Oxycodone (OxyContin)	265 mg Standard Deviation 246	244 mg Standard Deviation 159
Pain Medication Usage (Milligrams Used) Ibuprofen (Motrin)	14013 mg Standard Deviation 18109	9753 mg Standard Deviation 11509
Pain Medication Usage (Milligrams Used) Acetaminophen (Tylenol)	30615 mg Standard Deviation 13196	31287 mg Standard Deviation 13185

PRIMARY outcome

Timeframe: 1 week after surgery

Subjects recorded oral intake over one week after surgery

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=15 Participants 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.	No Treatment n=18 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Oral Intake (Patient Recorded Oral Intake)	13715 mL Standard Deviation 7551	12492 mL Standard Deviation 4271

SECONDARY outcome

Timeframe: 4 weeks

Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=15 Participants 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.	No Treatment n=18 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) Allergic reaction	0 Participants	0 Participants
Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug) Swallowing dysfunction	0 Participants	0 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=17 Participants 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.	No Treatment n=18 Participants Patient will not be given any medications in the tonsillar fossae after tonsillectomy
Number of Subjects With Post-tonsillectomy Bleeding Any form of bleeding	4 Participants	2 Participants
Number of Subjects With Post-tonsillectomy Bleeding Required a trip back to the operating room	2 Participants	1 Participants
Number of Subjects With Post-tonsillectomy Bleeding No bleeding	11 Participants	15 Participants

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Price

Mayo Clinic

Phone: 507-293-4395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place