TendonitisPhase 4NCT04867369

Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

A Phase 4 study testing Bupivacaine 20mL 0.5%, Bupivacaine 20mL 0.25% and Bupivacaine up to 15mL 0.25% in people with Tendonitis, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Tendonitis
What is being tested?: Bupivacaine 20mL 0.5%, Bupivacaine 20mL 0.25% and Bupivacaine up to 15mL 0.25%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2021to 11 Nov 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18 and 75 years of age
Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

Who cannot join

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients with diagnosed or self-reported cognitive dysfunction;
Patients with a history of neurologic disorder that can interfere with pain sensation;
Patients with a history of drug or recorded alcohol abuse;

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Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
Patients with a BMI over 45;
Any patient that the investigators feel cannot comply with all study related procedures;
NYU Langone Health students, residents, faculty or staff members.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

Conditions: Tendonitis
Being tested: Bupivacaine 20mL 0.5%, Bupivacaine 20mL 0.25%, Bupivacaine up to 15mL 0.25%
Medical subject headings: Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine 20mL 0.5%Drug
Interscalene nerve block with 20 mL 0.5% bupivacaine.
Bupivacaine 20mL 0.25%Drug
Pecs II fascial plane block with 20 mL 0.25% bupivacaine.
Bupivacaine up to 15mL 0.25%Drug
Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.

Study groups in NCT04867369
Study group	Role	What they receive
Pecs II block	Experimental	80 patients scheduled for open biceps tenodesis Receives: Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine 20mL 0.25%
Surgical infiltration	Active comparator	80 patients scheduled for open biceps tenodesis Receives: Drug: Bupivacaine 20mL 0.5%; Drug: Bupivacaine up to 15mL 0.25%

What is being measured

The primary outcome is the main question the study is designed to answer.

Opioid Utilization for the First 24 Hours After Surgery
Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.
Measured: Up to 24-Hours Post-Operation

Secondary outcomes (6)

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.
Measured: Typically 1-3 Hours Post-Operation
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.
Measured: 24 Hours Post-Operation
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.
Measured: Day 3 Post-Operation
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement
Number of patients with movement during incision.
Measured: Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia
Number of patients with tachycardia during incision.
Measured: Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep
Number of patients with sensation in bicep during incision.
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202111 Nov 2023

First posted30 Apr 2021
Study start14 Jul 2021
Primary completion8 Nov 2023
Study completion11 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TendonitisStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04867369
Sponsor's protocol ID: 20-01978
Status last verified: Dec 2024
First submitted: 28 Apr 2021
Last updated: 13 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Uchenna.Umeh@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
ClinicalTrials.gov ID: NCT04867369
Acronym / sponsor ID: 20-01978
Conditions: Tendonitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 14 Jul 2021 (actual)
Primary completion: 8 Nov 2023 (actual)
Study completion: 11 Nov 2023 (actual)
First posted: 30 Apr 2021 (actual)
Results: Posted 13 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Pecs II block	Experimental	Drug: Bupivacaine 20mL 0.5%, Drug: Bupivacaine 20mL 0.25%80 patients scheduled for open biceps tenodesis
Surgical infiltration	Active comparator	Drug: Bupivacaine 20mL 0.5%, Drug: Bupivacaine up to 15mL 0.25%80 patients scheduled for open biceps tenodesis

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients between 18 and 75 years of age
Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

Key exclusion criteria (12 listed)

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients with diagnosed or self-reported cognitive dysfunction;
Patients with a history of neurologic disorder that can interfere with pain sensation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine 20mL 0.5%Interscalene nerve block with 20 mL 0.5% bupivacaine.	Drug	Pecs II block, Surgical infiltration
Bupivacaine 20mL 0.25%Pecs II fascial plane block with 20 mL 0.25% bupivacaine.	Drug	Pecs II block
Bupivacaine up to 15mL 0.25%Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL.	Drug	Surgical infiltration

Primary outcome

Opioid Utilization for the First 24 Hours After Surgery
Time frame: Up to 24-Hours Post-Operation
Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery.

6 secondary outcomes

Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)
Time frame: Typically 1-3 Hours Post-Operation
Patient-reported Numerical Rating Scale (NRS) Score
Time frame: 24 Hours Post-Operation
Patient-reported Numerical Rating Scale (NRS) Score
Time frame: Day 3 Post-Operation
Number of Patients With Reactions to Surgical Subpectoral Incision - Movement
Time frame: Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia
Time frame: Intraoperative
Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep
Time frame: Intraoperative

Results and safety

Results posted to the registry on 13 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pecs II Block	80	79
Surgical Infiltration	80	80

Primary outcome: Opioid Utilization for the First 24 Hours After Surgery

Time frame: Up to 24-Hours Post-Operation. Median (Inter-Quartile Range). Unit: morphine milligram equivalents

Measure	Pecs II Block n = 80	Surgical Infiltration n = 80
Value	17.5 (10.0 to 27.5)	20 (10.0 to 30.0)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events with start dates occurring any time after informed consent is obtained (baseline) until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, up to 34 days total.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pecs II Block	0 of 80 (0%)	0 of 80 (0%)	0 of 80
Surgical Infiltration	0 of 80 (0%)	0 of 80 (0%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Uchenna.Umeh@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arthur Hertling, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine 20mL 0.5%, Bupivacaine 20mL 0.25% and Bupivacaine up to 15mL 0.25% in people with Tendonitis, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Utilization for the First 24 Hours After Surgery (time frame: Up to 24-Hours Post-Operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.