Opioid Use, Postoperative Pain, Thoracic Diseases
Conditions
Keywords
Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery
Brief summary
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
Interventions
DRUGLiposomal bupivacaine
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
DRUGBupivacaine Injection
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Syringe with Obscuring Over-Wrap
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Robotic or Video-Assisted Lung Resection for All Indications
Exclusion criteria
* Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy) * Extra-Thoracic Procedures * Hypersensitivity to Amide Local Analgesia * Cardiac Conduction Abnormalities * Hepatic Dysfunction * Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily In-Hospital Use of Opioids | Average over Entire Length of Hospitalization (Up to 1 Week) | Measured in Oral Morphine Equivalents per Day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily In-Hospital Pain Score | Average over Length of Hospitalization - Up to 1 Week | Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain). |
| Number of Participants With Postoperative Pneumonia | Index Hospitalization following Surgery until Discharge - Up to 1 Week | Pneumonia (Y/N) |
| Length of Stay | Index Hospitalization following Surgery until Discharge - Up to 1 Week | Measured in Days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. | 41 |
| Standard Bupivacaine Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. | 39 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Standard Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 69 years | 67 years | 69 years |
| Primary Lung Cancer | 35 Participants | 36 Participants | 71 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 28 Participants | 57 Participants |
| Region of Enrollment United States | 41 Participants | 39 Participants | 80 Participants |
| Robotic Surgery | 39 Participants | 39 Participants | 78 Participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
| Smoker | 21 Participants | 23 Participants | 44 Participants |
| Sublobar Resection | 32 Participants | 28 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 |
Outcome results
Primary
Average Daily In-Hospital Use of Opioids
Measured in Oral Morphine Equivalents per Day
Time frame: Average over Entire Length of Hospitalization (Up to 1 Week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Average Daily In-Hospital Use of Opioids | 40 Oral Morphine Equivalent per Day | Standard Deviation 28 |
| Standard Bupivacaine | Average Daily In-Hospital Use of Opioids | 45 Oral Morphine Equivalent per Day | Standard Deviation 27 |
Secondary
Average Daily In-Hospital Pain Score
Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).
Time frame: Average over Length of Hospitalization - Up to 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Average Daily In-Hospital Pain Score | 2.7 Units on a Scale | Standard Deviation 1.7 |
| Standard Bupivacaine | Average Daily In-Hospital Pain Score | 3.1 Units on a Scale | Standard Deviation 1.7 |
Secondary
Length of Stay
Measured in Days
Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Length of Stay | 2.2 Days | Standard Deviation 1.1 |
| Standard Bupivacaine | Length of Stay | 2.3 Days | Standard Deviation 1.3 |
Secondary
Number of Participants With Postoperative Pneumonia
Pneumonia (Y/N)
Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liposomal Bupivacaine | Number of Participants With Postoperative Pneumonia | 0 Participants |
| Standard Bupivacaine | Number of Participants With Postoperative Pneumonia | 1 Participants |