Trial Outcomes & Findings for Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis (NCT NCT04867369)

NCT ID: NCT04867369

Last Updated: 2024-12-13

Results Overview

Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 160 participants
• Primary outcome timeframe: Up to 24-Hours Post-Operation
• Results posted on: 2024-12-13

Participant Flow

Participant milestones

Measure	Pecs II Block 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Overall Study STARTED	80	80
Overall Study COMPLETED	79	80
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Pecs II Block 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Baseline characteristics by cohort

Measure	Pecs II Block n=79 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.	Total n=159 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 11.78 • n=5 Participants	55 years STANDARD_DEVIATION 11.785 • n=7 Participants	55 years STANDARD_DEVIATION 11.783 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	35 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	45 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	56 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 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	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	37 Participants n=7 Participants	69 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	30 Participants n=5 Participants	22 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	79 participants n=5 Participants	80 participants n=7 Participants	159 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24-Hours Post-Operation

Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.

Outcome measures

Measure	Pecs II Block n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Opioid Utilization for the First 24 Hours After Surgery	17.5 morphine milligram equivalents Interval 10.0 to 27.5	20 morphine milligram equivalents Interval 10.0 to 30.0

SECONDARY outcome

Timeframe: Typically 1-3 Hours Post-Operation

In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.

Outcome measures

Measure	Pecs II Block n=74 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=78 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)	0.5 score on a scale Interval 0.0 to 4.0	0 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 24 Hours Post-Operation

In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.

Outcome measures

Measure	Pecs II Block n=66 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=60 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Patient-reported Numerical Rating Scale (NRS) Score	2.5 score on a scale Interval 0.0 to 6.0	3 score on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Day 3 Post-Operation

In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain.

Outcome measures

Measure	Pecs II Block n=60 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=55 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Patient-reported Numerical Rating Scale (NRS) Score	1.5 score on a scale Interval 0.0 to 5.0	3 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Intraoperative

Number of patients with movement during incision.

Outcome measures

Measure	Pecs II Block n=75 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement	19 Participants	17 Participants

SECONDARY outcome

Timeframe: Intraoperative

Number of patients with tachycardia during incision.

Outcome measures

Measure	Pecs II Block n=76 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia	14 Participants	19 Participants

SECONDARY outcome

Timeframe: Intraoperative

Number of patients with sensation in bicep during incision.

Outcome measures

Measure	Pecs II Block n=73 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Surgical Infiltration n=80 Participants 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep	30 Participants	32 Participants

Adverse Events

Pecs II Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgical Infiltration

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

Arthur Hertling, MD

NYU Langone Health

Phone: 212-598-6085

Email: arthur.hertling@nyulangone.org

Results disclosure agreements

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