Lung Cancer
Conditions
Keywords
Video assisted thoracoscopic surgery, Serratus plane block, local infiltration
Brief summary
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon. Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores. The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance. The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.
Detailed description
Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.
Interventions
DRUGBupivacaine
20 cc 0.5%
133mg liposomal bupivacaine
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient, surgeon, and anesthesiologist in the case will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA (American Society of Anesthesiology) class I-IV * age 81-75
Exclusion criteria
* ASA class V * morbid obesity * patient refusal * patients with chronic pain or on pain medications * allergy to LA * patients receiving any additional regional techniques * coagulopathy * patients receiving systemic anticoagulation * local infection * procedures anticipated to last more than 5 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Opioid Consumption | up to 24 hours post procedure | The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Dose of Narcotic Administration | up to 24 hours post procedure | Time to first dose of narcotic administration post procedure |
| PACU Length of Stay | average 3-4 hours post procedure | The length of stay post procedure in the PACU |
| ICU Length of Stay | up to 40 hours post procedure | The length of stay post procedure in the or ICU |
| Visual Analogue Score (VAS) | up to 24 hours post procedure | Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain) |
| Patient Satisfaction Score | up to 24 hours post procedure | Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Serratus Plane Group Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. | 35 |
| Placebo Group Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. | 30 |
| Total | 65 |
Baseline characteristics
| Characteristic | Serratus Plane Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 53.29 years STANDARD_DEVIATION 17.24 | 64.30 years STANDARD_DEVIATION 11.01 | 58.37 years STANDARD_DEVIATION 15.6 |
| Race/Ethnicity, Customized Asian | 10 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants | 10 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 17 Participants | 11 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 30 |
| other Total, other adverse events | 0 / 35 | 0 / 30 |
| serious Total, serious adverse events | 0 / 35 | 0 / 30 |
Outcome results
Primary
Amount of Opioid Consumption
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
Time frame: up to 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serratus Plane Group | Amount of Opioid Consumption | 18.93 MME | Standard Deviation 19.16 |
| Placebo Group | Amount of Opioid Consumption | 13.21 MME | Standard Deviation 18.93 |
Secondary
ICU Length of Stay
The length of stay post procedure in the or ICU
Time frame: up to 40 hours post procedure
Population: only those participants who required an ICU stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serratus Plane Group | ICU Length of Stay | 32.57 hours | Standard Deviation 28.32 |
| Placebo Group | ICU Length of Stay | 40.00 hours | Standard Deviation 27.71 |
Secondary
PACU Length of Stay
The length of stay post procedure in the PACU
Time frame: average 3-4 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serratus Plane Group | PACU Length of Stay | 3.45 hours | Standard Deviation 2.41 |
| Placebo Group | PACU Length of Stay | 3.05 hours | Standard Deviation 1.66 |
Secondary
Patient Satisfaction Score
Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)
Time frame: up to 24 hours post procedure
Population: Data not collected
Secondary
Time to First Dose of Narcotic Administration
Time to first dose of narcotic administration post procedure
Time frame: up to 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serratus Plane Group | Time to First Dose of Narcotic Administration | 2.86 hours | Standard Deviation 4.17 |
| Placebo Group | Time to First Dose of Narcotic Administration | 3.09 hours | Standard Deviation 3.85 |
Secondary
Visual Analogue Score (VAS)
Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)
Time frame: up to 24 hours post procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serratus Plane Group | Visual Analogue Score (VAS) | at 2 hours | 3.09 score on a scale | Standard Deviation 2.85 |
| Serratus Plane Group | Visual Analogue Score (VAS) | at 18 hours | 2.17 score on a scale | Standard Deviation 2.94 |
| Serratus Plane Group | Visual Analogue Score (VAS) | at 6 hours | 3.03 score on a scale | Standard Deviation 2.71 |
| Serratus Plane Group | Visual Analogue Score (VAS) | at 24 hours | 1.89 score on a scale | Standard Deviation 2.26 |
| Serratus Plane Group | Visual Analogue Score (VAS) | baseline | 2.31 score on a scale | Standard Deviation 3.56 |
| Placebo Group | Visual Analogue Score (VAS) | at 24 hours | 1.93 score on a scale | Standard Deviation 2.57 |
| Placebo Group | Visual Analogue Score (VAS) | baseline | 2.80 score on a scale | Standard Deviation 3.65 |
| Placebo Group | Visual Analogue Score (VAS) | at 2 hours | 3.07 score on a scale | Standard Deviation 2.57 |
| Placebo Group | Visual Analogue Score (VAS) | at 6 hours | 3.23 score on a scale | Standard Deviation 3.02 |
| Placebo Group | Visual Analogue Score (VAS) | at 18 hours | 2.17 score on a scale | Standard Deviation 2.73 |