Trial Outcomes & Findings for Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery (NCT NCT03758261)

NCT ID: NCT03758261

Last Updated: 2023-07-03

Results Overview

Morphine equivalents (total OME)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: 1 day post catheter removal
• Results posted on: 2023-07-03

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	17	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

Baseline characteristics by cohort

Measure	Erector Spinae Nerve Block n=17 Participants 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.	Paravertebral Nerve Block n=16 Participants 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.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	64.47 years STANDARD_DEVIATION 13.51 • n=5 Participants	65.94 years STANDARD_DEVIATION 12.22 • n=7 Participants	65.18 years STANDARD_DEVIATION 12.92 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Weight (kg)	79.98 kilogram (kg) STANDARD_DEVIATION 23.04 • n=5 Participants	80.17 kilogram (kg) STANDARD_DEVIATION 17.79 • n=7 Participants	80.07 kilogram (kg) STANDARD_DEVIATION 20.66 • n=5 Participants
Height (cm)	167.35 centimeter (cm) STANDARD_DEVIATION 9.90 • n=5 Participants	165.21 centimeter (cm) STANDARD_DEVIATION 8.69 • n=7 Participants	166.31 centimeter (cm) STANDARD_DEVIATION 9.39 • n=5 Participants
BMI	28.54 kg/m^2 STANDARD_DEVIATION 8.33 • n=5 Participants	29.49 kg/m^2 STANDARD_DEVIATION 5.96 • n=7 Participants	29.00 kg/m^2 STANDARD_DEVIATION 7.29 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day post catheter removal

Morphine equivalents (total OME)

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Total Opioid Consumption	187.36 mg morphine equivalent (MME) Standard Deviation 184.35	164.70 mg morphine equivalent (MME) Standard Deviation 142.64

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Patient Reported Pain Scores	5.98 score on a scale Standard Deviation 2.21	5.16 score on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: 1 day post catheter removal

Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Amount Achieved on Incentive Spirometer	1221.15 milliliter (mL) Standard Deviation 480.77	1187.50 milliliter (mL) Standard Deviation 541.27

SECONDARY outcome

Timeframe: Up to 2 weeks on average

Length of hospital stay post-surgery

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Length of Hospital Stay	101.96 hours Standard Deviation 49.99	96.30 hours Standard Deviation 41.78

SECONDARY outcome

Timeframe: 6 days

How long catheter remains providing pain relief

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Time Catheter Remains Inserted in Body	21.99 hours Standard Deviation 12.96	21.94 hours Standard Deviation 11.91

SECONDARY outcome

Timeframe: 0-120 hours post-operative

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

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Averaged Total of Narcotic Usage	187.36 Average of OME Standard Deviation 190.82	164.7 Average of OME Standard Deviation 147.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Erector Spinae Nerve Block n=15 Participants 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.	Paravertebral Nerve Block n=15 Participants 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.
Report of Adverse Events From Catheter Placement	0 Participants	0 Participants

Adverse Events

Erector Spinae Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paravertebral Nerve Block

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Erector Spinae Nerve Block n=17 participants at risk 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.	Paravertebral Nerve Block n=16 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Respiratory Depression	0.00% 0/17 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.	6.2% 1/16 • Number of events 1 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.
Cardiac disorders Atrial Fibrillation	0.00% 0/17 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.	12.5% 2/16 • Number of events 2 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.
Surgical and medical procedures Redo Nerve Block	0.00% 0/17 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.	6.2% 1/16 • Number of events 1 • Adverse event data was collected from time of admission until patient discharge, an average of 4-days.

Additional Information

Dr. Charles Luke

University of Pittsburgh Medical Center

Phone: 4127485589

Email: lukecb@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place