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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Nerve Block | Other | Erector Spinae nerve block |
|
| Paravertebral Nerve Block | Other | Paravertebral nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral nerve block | Drug | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Luke, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29169795 | Background | D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4. | |
| 26897642 | Background | Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erector Spinae Nerve Block | Erector Spinae nerve block Erector Spinae nerve block: 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. |
| FG001 | Paravertebral Nerve Block | Paravertebral nerve block Paravertebral nerve block: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erector Spinae Nerve Block | Erector Spinae nerve block Erector Spinae nerve block: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Opioid Consumption | Morphine equivalents (total OME) | Posted | Mean | Standard Deviation | mg morphine equivalent (MME) | 1 day post catheter removal |
|
Adverse event data was collected from time of admission until patient discharge, an average of 4-days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erector Spinae Nerve Block | Erector Spinae nerve block Erector Spinae nerve block: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Respiratory Depression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Luke | University of Pittsburgh Medical Center | 4127485589 | lukecb@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2019 | Jun 13, 2023 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2020 | Jun 13, 2023 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2020 | Apr 28, 2023 | ICF_002.pdf |
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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.
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| Erector Spinae nerve block | Drug | 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. |
|
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 |
| 30292068 | Background | Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. |
| 28203765 | Background | Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available. |
| 28372654 | Background | Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available. |
|
| 29336785 | Background | Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish. |
| Paravertebral Nerve Block |
Paravertebral nerve block Paravertebral nerve block: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kilogram (kg) |
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| Height (cm) | Mean | Standard Deviation | centimeter (cm) |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day post catheter removal |
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|
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| Secondary | Amount Achieved on Incentive Spirometer | Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort | Posted | Mean | Standard Deviation | milliliter (mL) | 1 day post catheter removal |
|
|
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| Secondary | Length of Hospital Stay | Length of hospital stay post-surgery | Posted | Mean | Standard Deviation | hours | Up to 2 weeks on average |
|
|
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| Secondary | Time Catheter Remains Inserted in Body | How long catheter remains providing pain relief | Posted | Mean | Standard Deviation | hours | 6 days |
|
|
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| Secondary | Averaged Total of Narcotic Usage | Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME) | Posted | Mean | Standard Deviation | Average of OME | 0-120 hours post-operative |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 day post catheter removal |
|
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|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Paravertebral Nerve Block | Paravertebral nerve block Paravertebral nerve block: 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. | 0 | 16 | 0 | 16 | 4 | 16 |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | Patient went into atrial fibrillation. |
|
| Redo Nerve Block | Surgical and medical procedures | Non-systematic Assessment | The patient's nerve block had to be redone. |
|
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