Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)

Conditions
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Thoracic Surgical Procedures

Intervention / Treatment
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* Drug: Paravertebral nerve block
* Drug: Erector Spinae nerve block


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups of patients will be studied simultaneously. One group will have the intervention of the nerve block in the erector spinae approach and the other group will have the nerve block in the traditional paravertebral approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Erector Spinae Nerve Block<br>Erector Spinae nerve block | Drug: Erector Spinae nerve block<br>* The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.<br>|
| Other: Paravertebral Nerve Block<br>Paravertebral nerve block | Drug: Paravertebral nerve block<br>* The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption | Morphine equivalents (total OME) | 1 day post catheter removal | 
| Patient Reported Pain Scores | Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10. | 1 day post catheter removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount Achieved on Incentive Spirometer | Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort | 1 day post catheter removal | 
| Length of Hospital Stay | Length of hospital stay post-surgery | Up to 2 weeks on average | 
| Time Catheter Remains Inserted in Body | How long catheter remains providing pain relief | 6 days | 
| Averaged Total of Narcotic Usage | Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME) | 0-120 hours post-operative | 
| Report of Adverse Events From Catheter Placement | Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity. | 1 day post catheter removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VATS, Regional Anesthesia, Paravertebral nerve block, Erector Spinae nerve block, Video assisted thoracoscopic surgery