Thoracic Surgical Procedures
Conditions
Keywords
VATS, Regional Anesthesia, Paravertebral nerve block, Erector Spinae nerve block, Video assisted thoracoscopic surgery
Brief summary
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
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.
Interventions
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.
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.
Sponsors
Study design
Intervention 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.
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | 1 day post catheter removal | Morphine equivalents (total OME) |
| Patient Reported Pain Scores | 1 day post catheter removal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Catheter Remains Inserted in Body | 6 days | How long catheter remains providing pain relief |
| Amount Achieved on Incentive Spirometer | 1 day post catheter removal | Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort |
| Report of Adverse Events From Catheter Placement | 1 day post catheter removal | Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity. |
| Averaged Total of Narcotic Usage | 0-120 hours post-operative | Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME) |
| Length of Hospital Stay | Up to 2 weeks on average | Length of hospital stay post-surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Erector Spinae Nerve Block | Total | Paravertebral Nerve Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 20 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 13 Participants | 7 Participants |
| Age, Continuous | 64.47 years STANDARD_DEVIATION 13.51 | 65.18 years STANDARD_DEVIATION 12.92 | 65.94 years STANDARD_DEVIATION 12.22 |
| BMI | 28.54 kg/m^2 STANDARD_DEVIATION 8.33 | 29.00 kg/m^2 STANDARD_DEVIATION 7.29 | 29.49 kg/m^2 STANDARD_DEVIATION 5.96 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 33 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height (cm) | 167.35 centimeter (cm) STANDARD_DEVIATION 9.9 | 166.31 centimeter (cm) STANDARD_DEVIATION 9.39 | 165.21 centimeter (cm) STANDARD_DEVIATION 8.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 32 Participants | 15 Participants |
| Region of Enrollment United States | 17 participants | 33 participants | 16 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants |
| Weight (kg) | 79.98 kilogram (kg) STANDARD_DEVIATION 23.04 | 80.07 kilogram (kg) STANDARD_DEVIATION 20.66 | 80.17 kilogram (kg) STANDARD_DEVIATION 17.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 4 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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.
Time frame: 1 day post catheter removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Patient Reported Pain Scores | 5.98 score on a scale | Standard Deviation 2.21 |
| Paravertebral Nerve Block | Patient Reported Pain Scores | 5.16 score on a scale | Standard Deviation 2.66 |
Total Opioid Consumption
Morphine equivalents (total OME)
Time frame: 1 day post catheter removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Total Opioid Consumption | 187.36 mg morphine equivalent (MME) | Standard Deviation 184.35 |
| Paravertebral Nerve Block | Total Opioid Consumption | 164.70 mg morphine equivalent (MME) | Standard Deviation 142.64 |
Amount Achieved on Incentive Spirometer
Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort
Time frame: 1 day post catheter removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Amount Achieved on Incentive Spirometer | 1221.15 milliliter (mL) | Standard Deviation 480.77 |
| Paravertebral Nerve Block | Amount Achieved on Incentive Spirometer | 1187.50 milliliter (mL) | Standard Deviation 541.27 |
Averaged Total of Narcotic Usage
Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)
Time frame: 0-120 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Averaged Total of Narcotic Usage | 187.36 Average of OME | Standard Deviation 190.82 |
| Paravertebral Nerve Block | Averaged Total of Narcotic Usage | 164.7 Average of OME | Standard Deviation 147.64 |
Length of Hospital Stay
Length of hospital stay post-surgery
Time frame: Up to 2 weeks on average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Length of Hospital Stay | 101.96 hours | Standard Deviation 49.99 |
| Paravertebral Nerve Block | Length of Hospital Stay | 96.30 hours | Standard Deviation 41.78 |
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.
Time frame: 1 day post catheter removal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erector Spinae Nerve Block | Report of Adverse Events From Catheter Placement | 0 Participants |
| Paravertebral Nerve Block | Report of Adverse Events From Catheter Placement | 0 Participants |
Time Catheter Remains Inserted in Body
How long catheter remains providing pain relief
Time frame: 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erector Spinae Nerve Block | Time Catheter Remains Inserted in Body | 21.99 hours | Standard Deviation 12.96 |
| Paravertebral Nerve Block | Time Catheter Remains Inserted in Body | 21.94 hours | Standard Deviation 11.91 |