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Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

Primary Purpose

Tendonitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pecs II block
Surgical infiltration
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendonitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pecs II block

Surgical infiltration

Arm Description

80 patients scheduled for open biceps tenodesis

80 patients scheduled for open biceps tenodesis

Outcomes

Primary Outcome Measures

Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oxycodone equivalent

Secondary Outcome Measures

Patient reported Visual Analog Scale (VAS) scores in PACU
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Patient reported Visual Analog Scale (VAS) score at postoperative day 1 (POD 1)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Patient reported Visual Analog Scale (VAS) score at postoperative day 3 (POD 3)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Incidence of patient reaction to surgical subpectoral incision
signs include patient movement, tachycardia, etc.
Presence or absence of sensation to cold and pinprick in PACU
Alcohol skin testing in the axilla (distal to surgical dressing) will be done in PACU prior to discharge to evaluate the presence or absence of sensation to cold and pinprick in that area.

Full Information

First Posted
April 28, 2021
Last Updated
May 25, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04867369
Brief Title
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Official Title
Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pecs II block
Arm Type
Experimental
Arm Description
80 patients scheduled for open biceps tenodesis
Arm Title
Surgical infiltration
Arm Type
Active Comparator
Arm Description
80 patients scheduled for open biceps tenodesis
Intervention Type
Drug
Intervention Name(s)
Pecs II block
Intervention Description
Patients will receive an interscalene nerve block with 15 mL 0.5% bupivacaine + a Pecs II fascial plane block with 20 mL 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Surgical infiltration
Intervention Description
Patients will receive an interscalene nerve block with 20 mL 0.5% bupivacaine + local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL
Primary Outcome Measure Information:
Title
Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oxycodone equivalent
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Patient reported Visual Analog Scale (VAS) scores in PACU
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
24 hours
Title
Patient reported Visual Analog Scale (VAS) score at postoperative day 1 (POD 1)
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
24-48 hours
Title
Patient reported Visual Analog Scale (VAS) score at postoperative day 3 (POD 3)
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
72 hours
Title
Incidence of patient reaction to surgical subpectoral incision
Description
signs include patient movement, tachycardia, etc.
Time Frame
24 hours
Title
Presence or absence of sensation to cold and pinprick in PACU
Description
Alcohol skin testing in the axilla (distal to surgical dressing) will be done in PACU prior to discharge to evaluate the presence or absence of sensation to cold and pinprick in that area.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 18 and 75 years of age Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arthur Hertling, MD
Phone
212-598-6085
Email
Arthur.Hertling@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ekow Commeh
Phone
212-263-3851
Email
Ekow.commeh@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Hertling, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Hertling, MD
Phone
212-598-6085
Email
arthur.hertling@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Ekow Commeh
Phone
212-263-3851
Email
ekow.commeh@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Arthur Hertling, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required.
IPD Sharing Access Criteria
Requests may be directed to Uchenna.Umeh@nyulangone.org.

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Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis

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