Trial Outcomes & Findings for Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial (NCT NCT03508830)

NCT ID: NCT03508830

Last Updated: 2021-06-08

Results Overview

Measured in Oral Morphine Equivalents per Day

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 91 participants
• Primary outcome timeframe: Average over Entire Length of Hospitalization (Up to 1 Week)
• Results posted on: 2021-06-08

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Overall Study STARTED	46	45
Overall Study COMPLETED	41	39
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Measure	Liposomal Bupivacaine Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Overall Study Withdrawal by Subject	3	4
Overall Study Physician Decision	2	2

Baseline Characteristics

Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=41 Participants Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine n=39 Participants Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Total n=80 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	67 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	39 Participants n=7 Participants	80 Participants n=5 Participants
Smoker	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Primary Lung Cancer	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Robotic Surgery	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sublobar Resection	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Average over Entire Length of Hospitalization (Up to 1 Week)

Measured in Oral Morphine Equivalents per Day

Outcome measures

Measure	Liposomal Bupivacaine n=41 Participants Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine n=39 Participants Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Average Daily In-Hospital Use of Opioids	40 Oral Morphine Equivalent per Day Standard Deviation 28	45 Oral Morphine Equivalent per Day Standard Deviation 27

SECONDARY outcome

Timeframe: Average over Length of Hospitalization - Up to 1 Week

Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).

Outcome measures

Measure	Liposomal Bupivacaine n=41 Participants Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine n=39 Participants Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Average Daily In-Hospital Pain Score	2.7 Units on a Scale Standard Deviation 1.7	3.1 Units on a Scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Index Hospitalization following Surgery until Discharge - Up to 1 Week

Pneumonia (Y/N)

Outcome measures

Measure	Liposomal Bupivacaine n=41 Participants Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine n=39 Participants Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Number of Participants With Postoperative Pneumonia	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Index Hospitalization following Surgery until Discharge - Up to 1 Week

Measured in Days

Outcome measures

Measure	Liposomal Bupivacaine n=41 Participants Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.	Standard Bupivacaine n=39 Participants Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision.
Length of Stay	2.2 Days Standard Deviation 1.1	2.3 Days Standard Deviation 1.3

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Bupivacaine

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. Greg J. Haro

University of California, San Francisco

Phone: 415-353-7502

Email: greg.haro@ucsf.edu

Results disclosure agreements

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