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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04867369
Other study ID # 20-01978
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 14, 2021
Est. completion date November 11, 2023

Study information

Verified date February 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date November 11, 2023
Est. primary completion date November 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pecs II block
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
Surgical infiltration
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

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oxycodone equivalent 24 hours
Secondary 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." 24 hours
Secondary 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." 24-48 hours
Secondary 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." 72 hours
Secondary Incidence of patient reaction to surgical subpectoral incision signs include patient movement, tachycardia, etc. 24 hours
Secondary 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. 24 hours
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