Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | March 11, 2019 |
| End Date: | December 31, 2019 |
| Contact: | Neal K Shah, MD |
| Email: | shahnk2@upmc.edu |
| Phone: | 8473129191 |
Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted
techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic
pain following surgery and trauma. Recently, an increasing number of erector spinae plane
nerve blocks are being performed as it has been demonstrated in our institution, and via case
reports that the blocks provide clinical effectiveness, but may have a better side-effect
profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to
paravertebral nerve block remains to be established for video assisted thoracoscopic surgery
(VATS). This is a prospective randomized study intended to assess the efficacy, safety and
side-effect profile of continuous erector spinae plane analgesia versus continuous
paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC
Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve
block via continuous paravertebral infusion or via erector spinae plane infusion. In
addition, to treat breakthrough pain, the patients in both arms will receive multimodal
adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve
block catheters. The primary outcome will be to compare analgesic efficacy between the two
nerve blocks as defined by total opioid consumption and pain scores on the numeric pain
rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily
score postoperatively), length of stay, duration of catheter and report of adverse events or
complications. Other data points include number of chest tubes and location and level of
catheter and nerve block placement as well as number of blocks per case.
techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic
pain following surgery and trauma. Recently, an increasing number of erector spinae plane
nerve blocks are being performed as it has been demonstrated in our institution, and via case
reports that the blocks provide clinical effectiveness, but may have a better side-effect
profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to
paravertebral nerve block remains to be established for video assisted thoracoscopic surgery
(VATS). This is a prospective randomized study intended to assess the efficacy, safety and
side-effect profile of continuous erector spinae plane analgesia versus continuous
paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC
Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve
block via continuous paravertebral infusion or via erector spinae plane infusion. In
addition, to treat breakthrough pain, the patients in both arms will receive multimodal
adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve
block catheters. The primary outcome will be to compare analgesic efficacy between the two
nerve blocks as defined by total opioid consumption and pain scores on the numeric pain
rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily
score postoperatively), length of stay, duration of catheter and report of adverse events or
complications. Other data points include number of chest tubes and location and level of
catheter and nerve block placement as well as number of blocks per case.
Background and significance:
Multimodal analgesia for thoracic surgery is key to allow faster recovery and diminish
postoperative complications. Paravertebral nerve blocks as well as epidurals are among the
regional anesthetic techniques utilized for these procedures. Recently, a newer technique,
the erector spinae plane block, has been used and described to be effective in treating pain
for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically
significant pain control for thoracic surgery with both types of blocks. The previous case
reports/series and our clinical observation has led us to propose this study of comparing the
clinical efficacy of erector spinae plane block vs. paravertebral nerve block.
Though ESP and paravertebral blocks have been documented to be efficacious for this
procedure, there has been no direct comparison between the two approaches. The ESP block is
considered to be a safer technique with less theoretical adverse events possible and thus,
would become a viable alternative to the more technically challenging paravertebral nerve
block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain
management and safety, this would be a major finding, as ESP is considered safer and
technically easier to perform than paravertebral nerve block.
Study design and methods
The investigators present a prospective randomized trial comparing the efficacy of continuous
paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at
UPMC Passavant.
Multimodal analgesia for thoracic surgery is key to allow faster recovery and diminish
postoperative complications. Paravertebral nerve blocks as well as epidurals are among the
regional anesthetic techniques utilized for these procedures. Recently, a newer technique,
the erector spinae plane block, has been used and described to be effective in treating pain
for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically
significant pain control for thoracic surgery with both types of blocks. The previous case
reports/series and our clinical observation has led us to propose this study of comparing the
clinical efficacy of erector spinae plane block vs. paravertebral nerve block.
Though ESP and paravertebral blocks have been documented to be efficacious for this
procedure, there has been no direct comparison between the two approaches. The ESP block is
considered to be a safer technique with less theoretical adverse events possible and thus,
would become a viable alternative to the more technically challenging paravertebral nerve
block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain
management and safety, this would be a major finding, as ESP is considered safer and
technically easier to perform than paravertebral nerve block.
Study design and methods
The investigators present a prospective randomized trial comparing the efficacy of continuous
paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at
UPMC Passavant.
Inclusion criteria:
- Patients undergoing VATS agreeable to have a nerve block as analgesic technique
- Age: 18 years old and older.
- ASA (American Society of Anesthesiologists Class) I-IV
Exclusion criteria:
- Cognitive impairment that would not allow effective nerve block placement or gathering
information related to the study (ex. pain score).
- Contraindications for nerve block placement such as coagulopathy, use of clopidogrel
in the past 48hs, patients on dual antiplatelet therapy, infection at the site of
puncture, patient refusal, allergy to local anesthetics.
- Chronic opiate consumption
- Patient expected to be on therapeutic anticoagulation post procedure.
- Pregnancy
- Comorbid conditions: Any comorbid condition that in the judgment of the
anesthesiologist would preclude the patient from any aspect of the study (ex. sepsis,
possibly abnormalities of the thoracic spine or paravertebral anatomy such as
neoplastic mass occupying the space, empyema, increased intracranial pressure)
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