Trial Outcomes & Findings for Pectoralis Block vs Paravertebral Nerve Blocks for Breast Surgery (NCT NCT04742309)

Results Overview

Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes. Of note, in order to claim that Pecs-2 blocks are non-inferior to paravertebral blocks, both Hypotheses 1 and 2 must be at least non-inferior.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

119 participants

Primary outcome timeframe

From arrival in the recovery room until recovery room discharge, assessed up to 12 hours total

Results posted on

2024-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Pecs-2 For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine. Pecs-2 block (single injection): For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.	Paravertebral For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement. Paravertebral block (single injection): For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.
Overall Study STARTED	60	59
Overall Study COMPLETED	60	59
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

Baseline characteristics by cohort
Measure	Pecs-2 n=60 Participants For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine. Pecs-2 block (single injection): For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.	Paravertebral n=59 Participants For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement. Paravertebral block (single injection): For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.	Total n=119 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 15 • n=60 Participants	45 years STANDARD_DEVIATION 16 • n=59 Participants	50 years STANDARD_DEVIATION 16 • n=119 Participants
Sex: Female, Male Female	57 Participants n=60 Participants	57 Participants n=59 Participants	114 Participants n=119 Participants
Sex: Female, Male Male	3 Participants n=60 Participants	2 Participants n=59 Participants	5 Participants n=119 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	60 participants n=60 Participants	59 participants n=59 Participants	119 participants n=119 Participants
Height (cm)	165 cm STANDARD_DEVIATION 8 • n=60 Participants	165 cm STANDARD_DEVIATION 8 • n=59 Participants	165 cm STANDARD_DEVIATION 8 • n=119 Participants
Weight (kg)	70 kg STANDARD_DEVIATION 15 • n=60 Participants	70 kg STANDARD_DEVIATION 14 • n=59 Participants	70 kg STANDARD_DEVIATION 15 • n=119 Participants
Body mass index (kg/m2)	25.6 kg /m^2 STANDARD_DEVIATION 4.9 • n=60 Participants	25.7 kg /m^2 STANDARD_DEVIATION 5.1 • n=59 Participants	25.6 kg /m^2 STANDARD_DEVIATION 5.0 • n=119 Participants
Bilateral procedure (%)	36 Participants n=60 Participants	36 Participants n=59 Participants	72 Participants n=119 Participants

PRIMARY outcome

Timeframe: From arrival in the recovery room until recovery room discharge, assessed up to 12 hours total

Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes. Of note, in order to claim that Pecs-2 blocks are non-inferior to paravertebral blocks, both Hypotheses 1 and 2 must be at least non-inferior.

Outcome measures

Outcome measures
Measure	Pecs-2 n=60 Participants For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine. Pecs-2 block (single injection): For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.	Paravertebral n=59 Participants For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement. Paravertebral block (single injection): For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.
Recovery Room Numeric Rating Scale Pain Scores	3.3 score on a scale Interval 2.3 to 4.8	1.3 score on a scale Interval 0.0 to 3.6

PRIMARY outcome

Timeframe: From entering the operating room until recovery room discharge, assessed up to 24 hours

The morphine equivalents consumed in both the operating and recovery rooms. Of note, in order to claim that Pecs-2 blocks are non-inferior to paravertebral blocks, both Hypotheses 1 and 2 must be at least non-inferior.