Trial Outcomes & Findings for Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma (NCT NCT02749968)

NCT ID: NCT02749968

Last Updated: 2022-04-04

Results Overview

Opioid requirement (in morphine equivalents) at 24 hours post-randomization

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 24 hours following randomization.
• Results posted on: 2022-04-04

Participant Flow

To achieve an 80% power with an alpha of 0.05, the goal enrollment was 200 patients. Interim analyses were performed after 50 patients further providing evidence to support the 200 patient goal for enrollment. Due to changes in analgesia protocols away from epidural catheters and a change in exclusion criteria to include those who were candidates for surgical stabilization of rib fractures, as well as the COVID-19 pandemic, enrollment was stopped at 100 patients

Participant milestones

Measure	Liposomal Bupivacaine 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Overall Study STARTED	50	50
Overall Study Interim Analysis	25	25
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	Total n=100 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	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 18 • n=5 Participants	61 years STANDARD_DEVIATION 18 • n=7 Participants	60 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Incentive spirometry	17.8 Liters/min STANDARD_DEVIATION 8.1 • n=5 Participants	17.6 Liters/min STANDARD_DEVIATION 6.6 • n=7 Participants	17.7 Liters/min STANDARD_DEVIATION 7.39 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours following randomization.

Opioid requirement (in morphine equivalents) at 24 hours post-randomization

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Opioid Requirement at 24 Hours Post-randomization	38 morphine milligram equivalents Standard Deviation 959	202 morphine milligram equivalents Standard Deviation 691

PRIMARY outcome

Timeframe: 48 hours following randomization.

Opioid requirement (in morphine equivalents) at 48 hours post-randomization

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Opioid Requirement at 48 Hours Post-randomization.	298 morphine milligram equivalents Standard Deviation 1036	82 morphine milligram equivalents Standard Deviation 129

PRIMARY outcome

Timeframe: 72 hours following randomization.

Opioid requirement (in morphine equivalents) at 72 hours post-randomization

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Opioid Requirement at 72 Hours Post-randomization	413 morphine milligram equivalents Standard Deviation 1714	116 morphine milligram equivalents Standard Deviation 199

PRIMARY outcome

Timeframe: 96 hours following randomization.

Opioid requirement (in morphine equivalents) at 96 hours post-randomization

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Opioid Requirement at 96 Hours Post-randomization	637 morphine milligram equivalents Standard Deviation 2012	39 morphine milligram equivalents Standard Deviation 56

SECONDARY outcome

Timeframe: 96 hours following randomization

Development of pneumonia defined as >100,000 colony forming units/milliliter bacteria on bronchoalveolar lavage or clinically with leukocytosis, pulmonary infiltrate and fever with 96 hours post-randomization.

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Development of Pneumonia	3 Participants	1 Participants

SECONDARY outcome

Timeframe: At 96 hours post-randomization

Self-reported pain will be measured using the verbal NRS, a 0-10 ordinal scale. Pain assessments will be reported at 96 hours after enrollment, as this is the reported duration of effect for liposomal bupivacaine. Higher scores (10) indicate more pain, lower scores (0) indicate lower pain.

Outcome measures

Measure	Liposomal Bupivacaine n=50 Participants 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 Participants 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Self-reported Pain at 96 Hours Post-randomization	6.32 score on a scale Standard Deviation 2.73	6.44 score on a scale Standard Deviation 2.93

Adverse Events

Liposomal Bupivacaine

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

0.9% Sodium Chloride

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liposomal Bupivacaine n=50 participants at risk 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position Liposomal bupivacaine: 1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position	0.9% Sodium Chloride n=50 participants at risk 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position 0.9% sodium chloride: 1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
Respiratory, thoracic and mediastinal disorders pneumothorax	2.0% 1/50 • 96 hours	2.0% 1/50 • 96 hours
Respiratory, thoracic and mediastinal disorders intubation	6.0% 3/50 • 96 hours	2.0% 1/50 • 96 hours

Other adverse events

Adverse event data not reported

Additional Information

Michael Goodman

University of Cincinnati

Phone: 5135585661

Email: michael.goodman@uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place