Tendonitis
Conditions
Brief summary
A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.
Interventions
DRUGBupivacaine 20mL 0.5%
Interscalene nerve block with 20 mL 0.5% bupivacaine.
DRUGBupivacaine 20mL 0.25%
Pecs II fascial plane block with 20 mL 0.25% bupivacaine.
DRUGBupivacaine up to 15mL 0.25%
Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between 18 and 75 years of age 2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis
Exclusion criteria
1. Patients younger than 18 and older than 75; 2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; 3. Patients who are allergic to oxycodone; 4. Patients with diagnosed or self-reported cognitive dysfunction; 5. Patients with a history of neurologic disorder that can interfere with pain sensation; 6. Patients with a history of drug or recorded alcohol abuse; 7. Patients who are unable to understand or follow instructions; 8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; 9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; 10. Patients with a BMI over 45; 11. Any patient that the investigators feel cannot comply with all study related procedures; 12. NYU Langone Health students, residents, faculty or staff members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization for the First 24 Hours After Surgery | Up to 24-Hours Post-Operation | Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | 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. |
| Patient-reported Numerical Rating Scale (NRS) Score | 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. |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Movement | Intraoperative | Number of patients with movement during incision. |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia | Intraoperative | Number of patients with tachycardia during incision. |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep | Intraoperative | Number of patients with sensation in bicep during incision. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 79 |
| 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. | 80 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Pecs II Block | Total | Surgical Infiltration |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 11.78 | 55 years STANDARD_DEVIATION 11.783 | 55 years STANDARD_DEVIATION 11.785 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 41 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 104 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 14 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 27 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 52 Participants | 22 Participants |
| Race (NIH/OMB) White | 32 Participants | 69 Participants | 37 Participants |
| Region of Enrollment United States | 79 participants | 159 participants | 80 participants |
| Sex: Female, Male Female | 28 Participants | 63 Participants | 35 Participants |
| Sex: Female, Male Male | 51 Participants | 96 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Opioid Utilization for the First 24 Hours After Surgery
Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.
Time frame: Up to 24-Hours Post-Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pecs II Block | Opioid Utilization for the First 24 Hours After Surgery | 17.5 morphine milligram equivalents |
| Surgical Infiltration | Opioid Utilization for the First 24 Hours After Surgery | 20 morphine milligram equivalents |
Secondary
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement
Number of patients with movement during incision.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pecs II Block | Number of Patients With Reactions to Surgical Subpectoral Incision - Movement | 19 Participants |
| Surgical Infiltration | Number of Patients With Reactions to Surgical Subpectoral Incision - Movement | 17 Participants |
Secondary
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep
Number of patients with sensation in bicep during incision.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pecs II Block | Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep | 30 Participants |
| Surgical Infiltration | Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep | 32 Participants |
Secondary
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia
Number of patients with tachycardia during incision.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pecs II Block | Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia | 14 Participants |
| Surgical Infiltration | Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia | 19 Participants |
Secondary
Patient-reported Numerical Rating Scale (NRS) Score
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.
Time frame: Day 3 Post-Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pecs II Block | Patient-reported Numerical Rating Scale (NRS) Score | 1.5 score on a scale |
| Surgical Infiltration | Patient-reported Numerical Rating Scale (NRS) Score | 3 score on a scale |
Secondary
Patient-reported Numerical Rating Scale (NRS) Score
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.
Time frame: 24 Hours Post-Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pecs II Block | Patient-reported Numerical Rating Scale (NRS) Score | 2.5 score on a scale |
| Surgical Infiltration | Patient-reported Numerical Rating Scale (NRS) Score | 3 score on a scale |
Secondary
Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)
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.
Time frame: Typically 1-3 Hours Post-Operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pecs II Block | Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | 0.5 score on a scale |
| Surgical Infiltration | Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | 0 score on a scale |