We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749968
Recruitment Status : Completed
First Posted : April 25, 2016
Results First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Michael Goodman, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Blunt Chest Wall Trauma
Rib Fracture
Sternal Fracture
Interventions Drug: Liposomal bupivacaine
Drug: 0.9% sodium chloride
Enrollment 100
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 50 50
Interim Analysis [1] 25 25
Completed 50 50
Not Completed 0 0
[1]
Interim safety and efficacy analysis was performed after 25 patients were recruited to each arm.
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  80.0%
40
  80.0%
80
  80.0%
>=65 years
10
  20.0%
10
  20.0%
20
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
60  (18) 61  (18) 60  (18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
25
  50.0%
22
  44.0%
47
  47.0%
Male
25
  50.0%
28
  56.0%
53
  53.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
50
 100.0%
50
 100.0%
100
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Incentive spirometry  
Mean (Standard Deviation)
Unit of measure:  Liters/min
Number Analyzed 50 participants 50 participants 100 participants
17.8  (8.1) 17.6  (6.6) 17.7  (7.39)
1.Primary Outcome
Title Opioid Requirement at 24 Hours Post-randomization
Hide Description Opioid requirement (in morphine equivalents) at 24 hours post-randomization
Time Frame 24 hours following randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: morphine milligram equivalents
38  (959) 202  (691)
2.Primary Outcome
Title Opioid Requirement at 48 Hours Post-randomization.
Hide Description Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Time Frame 48 hours following randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: morphine milligram equivalents
298  (1036) 82  (129)
3.Primary Outcome
Title Opioid Requirement at 72 Hours Post-randomization
Hide Description Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Time Frame 72 hours following randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: morphine milligram equivalents
413  (1714) 116  (199)
4.Primary Outcome
Title Opioid Requirement at 96 Hours Post-randomization
Hide Description Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Time Frame 96 hours following randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: morphine milligram equivalents
637  (2012) 39  (56)
5.Secondary Outcome
Title Development of Pneumonia
Hide Description 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.
Time Frame 96 hours following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.0%
1
   2.0%
6.Secondary Outcome
Title Self-reported Pain at 96 Hours Post-randomization
Hide Description 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.
Time Frame At 96 hours post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.32  (2.73) 6.44  (2.93)
Time Frame 96 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomal Bupivacaine 0.9% Sodium Chloride
Hide Arm/Group Description

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

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

All-Cause Mortality
Liposomal Bupivacaine 0.9% Sodium Chloride
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Hide Serious Adverse Events
Liposomal Bupivacaine 0.9% Sodium Chloride
Affected / at Risk (%) Affected / at Risk (%)
Total   4/50 (8.00%)   2/50 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
pneumothorax   1/50 (2.00%)  1/50 (2.00%) 
intubation   3/50 (6.00%)  1/50 (2.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposomal Bupivacaine 0.9% Sodium Chloride
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Goodman
Organization: University of Cincinnati
Phone: 5135585661
EMail: michael.goodman@uc.edu
Layout table for additonal information
Responsible Party: Michael Goodman, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02749968    
Other Study ID Numbers: Droege 2016
First Submitted: April 18, 2016
First Posted: April 25, 2016
Results First Submitted: February 14, 2022
Results First Posted: April 4, 2022
Last Update Posted: April 4, 2022