Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Mount Sinai Health System

Status and phase: Terminated; Phase 4

Conditions: Lung Cancer

Treatments: Drug: Bupivacaine liposome; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03642457

GCO 17-1294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Serratus Plane Group

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine liposome

Drug: Bupivacaine

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine liposome