Trial Outcomes & Findings for Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery (NCT NCT01977352)

Results Overview

Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

Post op Day 1, post op Day 2, post op day 3, post op 1 week

Results posted on

2018-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomal Bupivacaine liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% 20 cc of bupivacaine 0.25%
Overall Study STARTED	21	21
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Liposomal Bupivacaine liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% 20 cc of bupivacaine 0.25%
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%	Total n=39 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 9.55 • n=5 Participants	54.69 years STANDARD_DEVIATION 9.45 • n=7 Participants	55.1 years STANDARD_DEVIATION 9.55 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post op Day 1, post op Day 2, post op day 3, post op 1 week

Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Total Opioid Consumption Post op Day 1	2 number of percocet tabs Standard Deviation 1.53	2.75 number of percocet tabs Standard Deviation 2.96
Total Opioid Consumption Post op Day 2	1.94 number of percocet tabs Standard Deviation 1.47	3.33 number of percocet tabs Standard Deviation 3.61
Total Opioid Consumption Post op Day 3	2.06 number of percocet tabs Standard Deviation 2.01	3.63 number of percocet tabs Standard Deviation 3.7
Total Opioid Consumption Post Op 1 Week	1.61 number of percocet tabs Standard Deviation 1.61	1.13 number of percocet tabs Standard Deviation 2.03

SECONDARY outcome

Timeframe: Post op Day 1, post op Day 2, post op day 3, post op 1 week

The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Quality of Analgesia Post op Day 1	5.23 units on a scale Standard Deviation 3.5	6.4 units on a scale Standard Deviation 2.15
Quality of Analgesia Post op Day 2	4.9 units on a scale Standard Deviation 3.4	6.13 units on a scale Standard Deviation 2.66
Quality of Analgesia Post op Day 3	5.18 units on a scale Standard Deviation 2.77	5.14 units on a scale Standard Deviation 3.08
Quality of Analgesia Post Op 1 Week	4.08 units on a scale Standard Deviation 2.88	3.66 units on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: at 20 min and at 1 hour

Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Sensory and Motor Block Sensory block at 20 min prior to surgery	1.6 units on a scale Standard Deviation 0.43	1.31 units on a scale Standard Deviation 0.42
Sensory and Motor Block Motor block at 20 min prior to surgery	2.8 units on a scale Standard Deviation 0.43	2.33 units on a scale Standard Deviation 0.7
Sensory and Motor Block Sensory block at 1 hour after arrival to PACU	1.78 units on a scale Standard Deviation 2.77	1.08 units on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Time to First Pain Medicine	1148 minutes Standard Deviation 1227.59	702.89 minutes Standard Deviation 273.06

SECONDARY outcome

Timeframe: 72 hours

data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Incidence of Postoperative Nausea and Vomiting	33.33 percentage of participants	36.84 percentage of participants

SECONDARY outcome

Timeframe: Post op Day 1, post op Day 2, post op day 3, post op 1 week

scale of 0-10, 0=horrible, up all night; 10=perfect sleep

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine n=20 Participants liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 Participants 20 cc of bupivacaine 0.25%
Sleep Quality Post op Day 1	5.06 units on a scale Standard Deviation 3.23	3.86 units on a scale Standard Deviation 2.37
Sleep Quality Post op Day 2	6.58 units on a scale Standard Deviation 2.74	6 units on a scale Standard Deviation 2.29
Sleep Quality Post op Day 3	6.75 units on a scale Standard Deviation 2.11	6.3 units on a scale Standard Deviation 2.46
Sleep Quality Post Op 1 Week	7.8 units on a scale Standard Deviation 1.67	7.65 units on a scale Standard Deviation 2.49

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine 0.25%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Liposomal Bupivacaine n=20 participants at risk liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)	Bupivacaine 0.25% n=19 participants at risk 20 cc of bupivacaine 0.25%
General disorders ED visit	0.00% 0/20	5.3% 1/19

Additional Information

Dr. Ali Shariat

Icahn School of Medicine at Mount Sinai

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place