Clinical trial NCT03642457: Efficacy Between Serratus Plane Block And Local Infiltration In Vats
Official title: Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lung Cancer
Keywords: Video assisted thoracoscopic surgery
Serratus plane block
local infiltration
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amount of Opioid Consumption
timeFrame: up to 24 hours post procedure
Secondary outcomes:
measure: Time to First Dose of Narcotic Administration
timeFrame: up to 24 hours post procedure
measure: PACU Length of Stay
timeFrame: average 3-4 hours post procedure
measure: ICU Length of Stay
timeFrame: up to 40 hours post procedure
measure: Visual Analogue Score (VAS)
timeFrame: up to 24 hours post procedure
measure: Patient Satisfaction Score
timeFrame: up to 24 hours post procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai St. Luke's Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai West Hospital
state: New York
Study officials:
affiliation: cahn School of Medicine at Mount Sinai
name: Yan Lai, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
citation: Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
citation: Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.