Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Bupivacaine

Anesthetics

Anesthetics, Local

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.

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.

Bupivacaine liposome

Yan Lai, MD, MPH

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.

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.

The patient, surgeon, and anesthesiologist in the case will be blinded.

Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial

The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.

Time to first dose of narcotic administration post procedure

The length of stay post procedure in the PACU

The length of stay post procedure in the or ICU

Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)

Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)

Icahn School of Medicine at Mount Sinai

Assistant Professor

Serratus Plane Group

Placebo Group

Total

Age, Continuous

Sex: Female, Male

Asian

Black or African American

Hispanic or Latino

White

Race/Ethnicity, Customized

Poonam Pai

Amount of Opioid Consumption

Time to First Dose of Narcotic Administration

PACU Length of Stay

only those participants who required an ICU stay

ICU Length of Stay

baseline

at 2 hours

at 6 hours

at 18 hours

at 24 hours

Visual Analogue Score (VAS)

Patient Satisfaction Score

Overall Study

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

TAP block with 30 mL 0.25% bupivacaine mixed with 10 mL normal saline for a total of 40 mL per side

TAP block with 10mL liposomal bupivacaine, 20mL 0.25% bupivacaine, and 10mL normal saline for a total of 40 mL per side

normal saline

Daniel Katz, MD

James Leader

The study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. The study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

After consent, patients will be randomized to either liposomal bupivacaine Transversus Abdominal Plane (TAP) vs standard bupivacaine TAP. Blocks will occur post induction and pre incision. Only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. The entire care team and the patient will be blinded. A standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. Patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Double blind randomized control trial with intervention arm as liposomal bupivacaine tap and intervention as standard bupivacaine tap

The only people who will be unblinded are the members of the block team, who are not members of the care team nor the study team. They will open the envelopes, draw up the medications and cover the syringes with opaque paper such that no one can tell the contents.

Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy

Effect of Transversus Abdominal Plane Block Using Liposomal Bupivacaine Versus Standard Bupivacaine for Open Myomectomy: A Prospective Randomized Control Trial

Total cumulative opiates consumed converted to morphine equivalents

Composite score of minimal opiate dose and additionally scores of 0 on questions 2,3,4,5,6 on OBAS scoring scale.

Overall Benefit of Analgesic Score (OBAS) scoring scale -total scale from 0-20, low score indicates high benefit.

15 question quality of recovery scale, full scale from 0-150, with lower score indicating better recovery.

Sum of pain scores at 24, 48, 72, and 96 hours. Pain scale from 0-10, with higher score indicating worst pain.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Between Serratus Plane Block And Local Infiltration In Vats	NCT03642457	Lung Cancer	Bupivacaine Bupivacaine lip...	18 Years - 75 Years	Icahn School of Medicine at Mount Sinai
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy	NCT04272086	Fibroid Uterus	Bupivacaine Bupivacaine lip... normal saline	18 Years - 64 Years	Icahn School of Medicine at Mount Sinai
Utility of Liposomal Bupivacaine Transversus Abdominal Plane Block for Open Myomectomy	NCT04272086	Fibroid Uterus	Bupivacaine Bupivacaine lip... normal saline	18 Years - 64 Years	Icahn School of Medicine at Mount Sinai
Efficacy Between Serratus Plane Block And Local Infiltration In Vats	NCT03642457	Lung Cancer	Bupivacaine Bupivacaine lip...	18 Years - 75 Years	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for bupivacaine liposome