Randomized Clinical Trial of Erector Spinae Plane (ESP) Versus Paravertebral Nerve (PVB) Blockade for Video Assisted Thoracoscopic Surgery (VATS)
| Registry | NCT03758261 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 35 (Actual) |
| Sponsor | Charles Luke (Other) |
| Conditions | Thoracic Surgical Procedures |
| Interventions | Paravertebral nerve block, Erector Spinae nerve block (Drug) |
| Dates | start 2019-03-11, primary completion 2020-06-12, completion 2020-06-25, first posted 2018-11-29, last updated 2023-07-03 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Erector Spinae Nerve Block | Other | Drug: Erector Spinae nerve block | Erector Spinae nerve block |
| Paravertebral Nerve Block | Other | Drug: Paravertebral nerve block | Paravertebral nerve block |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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)
| Milestone | Erector Spinae Nerve Block | Paravertebral Nerve Block |
|---|---|---|
| Started | 17 | 16 |
| Completed | 15 | 15 |
| Not completed | 2 | 1 |
Time frame: Adverse event data was collected from time of admission until patient discharge, an average of 4-days.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Erector Spinae Nerve Block | 0/17 (0.0%) | 0/17 (0.0%) | 0/17 (0.0%) |
| Paravertebral Nerve Block | 0/16 (0.0%) | 0/16 (0.0%) | 4/16 (25.0%) |
| Term | Organ system | Erector Spinae Nerve Block | Paravertebral Nerve Block |
|---|---|---|---|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | 0/17 | 1/16 |
| Atrial Fibrillation | Cardiac disorders | 0/17 | 2/16 |
| Redo Nerve Block | Surgical and medical procedures | 0/17 | 1/16 |
| Facility | City | Country | Status |
|---|---|---|---|
| UPMC Passavant | Pittsburgh, Pennsylvania | United States |