Efficacy Between Serratus Plane Block And Local Infiltration In Vats
- Registration Number
- NCT03642457
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
- ASA (American Society of Anesthesiology) class I-IV
- age 81-75
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Serratus Plane Group Bupivacaine 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. Serratus Plane Group Bupivacaine liposome 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. Placebo Group Bupivacaine liposome 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (2)
Mount Sinai West Hospital
🇺🇸New York, New York, United States
Mount Sinai St. Luke's Hospital
🇺🇸New York, New York, United States