Trial Outcomes & Findings for Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC) (NCT NCT03152929)

Results Overview

Participants for whom Narcotics were used for pain during surgery

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

89 participants

Primary outcome timeframe

intraoperatively, average of about 1 hour

Results posted on

2023-06-06

Participant Flow

enrollment was stopped prematurely as the Standard of Care changed due to rising evidence during the enrollment period.

Participant milestones

Participant milestones
Measure	Paravertebral Block The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Overall Study STARTED	40	49
Overall Study COMPLETED	40	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine	Total n=89 Participants Total of all reporting groups
Age, Continuous	65.15 years STANDARD_DEVIATION 10.18 • n=5 Participants	64.24 years STANDARD_DEVIATION 11.42 • n=7 Participants	64.65 years STANDARD_DEVIATION 10.83 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	49 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	48 Participants n=7 Participants	87 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	40 participants n=5 Participants	49 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: intraoperatively, average of about 1 hour

Participants for whom Narcotics were used for pain during surgery

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Intraoperative Narcotic Use	26 Participants	29 Participants

PRIMARY outcome

Timeframe: in PACU, generally 1-3 hours

Participants for whom Narcotics were used in PACU

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Post Anesthesia Care Unit (PACU) Narcotic Use	20 Participants	33 Participants

PRIMARY outcome

Timeframe: First 24 hours post-PACU (or until discharge)

Participants for whom Narcotics were used postoperatively

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Postoperative Narcotic Use	3 Participants	1 Participants

SECONDARY outcome

Timeframe: intraoperative

Measuring pain control by how long (in minutes) patient is in surgery

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Pain Control Measured by Length of Operation	61.80 minutes Standard Deviation 16.42	64.14 minutes Standard Deviation 20.20

SECONDARY outcome

Timeframe: intraoperative

Measuring blood loss (in ml) during surgery

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Pain Control Measured by Estimated Blood Loss	10.85 milliliters Standard Deviation 8.3	13.8 milliliters Standard Deviation 12.29

SECONDARY outcome

Timeframe: 2 weeks postoperative

Population: Paravertebral population had one non-reporting participant

count of participants who reported nausea after surgery

Outcome measures

Outcome measures
Measure	Paravertebral Block n=39 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Participants With Postoperative Nausea	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 2 weeks postoperative

Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.

Outcome measures

Outcome measures
Measure	Paravertebral Block n=40 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Pain Control Measured by Pain Scale	2 score on a scale Standard Deviation 1.33	2.4 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 2 weeks postoperative

Population: Paravertebral Block arm had one participant with no response

Participants who used narcotic pain pills postoperatively

Outcome measures

Outcome measures
Measure	Paravertebral Block n=39 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=49 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Pain Control Measured by the Use of Pain Pills Postoperatively	20 Participants	24 Participants

SECONDARY outcome

Timeframe: 2 weeks postoperative

Population: one participant in each arm did not have a response recorded

Number of phone calls made to physician office regarding pain

Outcome measures

Outcome measures
Measure	Paravertebral Block n=39 Participants The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Paravertebral Block: 20-30 mL 0.5% Ropivacaine	Pectoral Nerve Block n=48 Participants The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine) Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Pain Control Measured by Calls to Physicians Office Relating to Pain no phone calls to physician office regarding pain	38 Participants	44 Participants
Pain Control Measured by Calls to Physicians Office Relating to Pain 1 phone call to physician office regarding pain	1 Participants	4 Participants

Adverse Events

Paravertebral Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pectoral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marianne Melnik

Spectrum Health

Phone: 616-486-6333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place