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Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758261
Enrollment
35
Registered
2018-11-29
Start date
2019-03-11
Completion date
2020-06-25
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgical Procedures

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

Charles Luke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Total Opioid Consumption1 day post catheter removalMorphine equivalents (total OME)
Patient Reported Pain Scores1 day post catheter removalVisual 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

MeasureTime frameDescription
Time Catheter Remains Inserted in Body6 daysHow long catheter remains providing pain relief
Amount Achieved on Incentive Spirometer1 day post catheter removalAmount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort
Report of Adverse Events From Catheter Placement1 day post catheter removalParticipant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.
Averaged Total of Narcotic Usage0-120 hours post-operativeAveraged total Narcotic consumption measured in Oral Morphine Equivalence (OME)
Length of Hospital StayUp to 2 weeks on averageLength of hospital stay post-surgery

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total33

Baseline characteristics

CharacteristicErector Spinae Nerve BlockTotalParavertebral Nerve Block
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants20 Participants9 Participants
Age, Categorical
Between 18 and 65 years
6 Participants13 Participants7 Participants
Age, Continuous64.47 years
STANDARD_DEVIATION 13.51
65.18 years
STANDARD_DEVIATION 12.92
65.94 years
STANDARD_DEVIATION 12.22
BMI28.54 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 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants33 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants32 Participants15 Participants
Region of Enrollment
United States
17 participants33 participants16 participants
Sex: Female, Male
Female
7 Participants17 Participants10 Participants
Sex: Female, Male
Male
10 Participants16 Participants6 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 16
other
Total, other adverse events
0 / 174 / 16
serious
Total, serious adverse events
0 / 170 / 16

Outcome results

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.

Time frame: 1 day post catheter removal

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockPatient Reported Pain Scores5.98 score on a scaleStandard Deviation 2.21
Paravertebral Nerve BlockPatient Reported Pain Scores5.16 score on a scaleStandard Deviation 2.66
Primary

Total Opioid Consumption

Morphine equivalents (total OME)

Time frame: 1 day post catheter removal

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockTotal Opioid Consumption187.36 mg morphine equivalent (MME)Standard Deviation 184.35
Paravertebral Nerve BlockTotal Opioid Consumption164.70 mg morphine equivalent (MME)Standard Deviation 142.64
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockAmount Achieved on Incentive Spirometer1221.15 milliliter (mL)Standard Deviation 480.77
Paravertebral Nerve BlockAmount Achieved on Incentive Spirometer1187.50 milliliter (mL)Standard Deviation 541.27
Secondary

Averaged Total of Narcotic Usage

Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)

Time frame: 0-120 hours post-operative

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockAveraged Total of Narcotic Usage187.36 Average of OMEStandard Deviation 190.82
Paravertebral Nerve BlockAveraged Total of Narcotic Usage164.7 Average of OMEStandard Deviation 147.64
Secondary

Length of Hospital Stay

Length of hospital stay post-surgery

Time frame: Up to 2 weeks on average

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockLength of Hospital Stay101.96 hoursStandard Deviation 49.99
Paravertebral Nerve BlockLength of Hospital Stay96.30 hoursStandard Deviation 41.78
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.

Time frame: 1 day post catheter removal

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Erector Spinae Nerve BlockReport of Adverse Events From Catheter Placement0 Participants
Paravertebral Nerve BlockReport of Adverse Events From Catheter Placement0 Participants
Secondary

Time Catheter Remains Inserted in Body

How long catheter remains providing pain relief

Time frame: 6 days

ArmMeasureValue (MEAN)Dispersion
Erector Spinae Nerve BlockTime Catheter Remains Inserted in Body21.99 hoursStandard Deviation 12.96
Paravertebral Nerve BlockTime Catheter Remains Inserted in Body21.94 hoursStandard Deviation 11.91

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026