Trial Outcomes & Findings for Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery (NCT NCT03549234)

NCT ID: NCT03549234

Last Updated: 2020-07-24

Results Overview

Range scale minimum 0, maximum 10. Lower pain scores are considered a better outcome, higher pain scores are considered a worse outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 1 day (PACU pain scores)
• Results posted on: 2020-07-24

Participant Flow

Participant milestones

Measure	Erector Spinae (Single Injection) Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=50 Participants	33 Participants n=50 Participants	72 Participants n=100 Participants
Age, Categorical >=65 years	11 Participants n=50 Participants	17 Participants n=50 Participants	28 Participants n=100 Participants
Age, Continuous	54.5 years n=50 Participants	54.5 years n=50 Participants	54.5 years n=100 Participants
Sex: Female, Male Female	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: 1 day (PACU pain scores)

Range scale minimum 0, maximum 10. Lower pain scores are considered a better outcome, higher pain scores are considered a worse outcome.

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Numeric Rating Scale Pain Scores	3.0 score on a scale Interval 0.25 to 5.0	0 score on a scale Interval 0.0 to 3.13

PRIMARY outcome

Timeframe: up to 1 day, in the OR and PACU

This outcome measure reflects the total amount of opioid administered in the operating room and recovery room perioperatively. Specific time points are not applicable since operating room and recovery room times differ among subjects.

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
OR and PACU Opioid Consumption	2.0 morphine equivalents Interval 1.14 to 4.52	1.4 morphine equivalents Interval 1.0 to 2.07

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day 1

Nausea and vomiting was recorded using a 0-10 Likert scale (0 = no nausea; 10 = vomiting) on postoperative day 1. Higher scores represent a worse outcome.

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Nausea and Vomiting	0 score on a scale Interval 0.0 to 0.0	0 score on a scale Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day 1

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Sleep Disturbances	0 awakenings Interval 0.0 to 0.0	0 awakenings Interval 0.0 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day 1

This was recorded as the time at which a participant subjectively noticed that the nerve block was wearing off and sensation was returning.

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Time of Block Resolution	17.7 hours Interval 9.66 to 20.07	16.0 hours Interval 11.88 to 19.93

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative day 1

Number of oxycodone tablets (in mg) taken by the participant after discharge from the recovery room was recorded during follow-up on postoperative day 1.

Outcome measures

Measure	Erector Spinae (Single Injection) n=50 Participants Erector Spinae (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.	Paravertebral (Single Injection) n=50 Participants Paravertebral (single injection): Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
Opioid Consumption	5 mg oxycodone Interval 0.0 to 10.0	10 mg oxycodone Interval 0.0 to 15.0

Adverse Events

Erector Spinae (Single Injection)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paravertebral (Single Injection)

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

Matthew Swisher, MD

University of California San Diego

Phone: 415-314-4099

Email: matthew.swisher@gmail.com

Results disclosure agreements

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