Skip to main content
OpenTrials
Completed

NCT Number: NCT04047446

Liposomal Bupivacaine vs Dexamethasone ISB

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III
  • Age 18 years or older
  • Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion criteria

  • History of allergy to local anesthetic, or one of the study medications
  • Pre-existing neurological deficits
  • Psychiatric or cognitive disorders that prohibit patients from following study protocol
  • History of drug or alcohol abuse
  • Chronic opioid use (longer than 3 months)
  • Chronic pain syndromes
  • Infection at the site of injection
  • Patients with severe pulmonary disease
  • Herniated cervical disc, cervical myelopathy
  • Contraindication for general anesthesia and/or interscalene nerve block
  • Pregnancy
  • Open shoulder arthrotomies.
  • Non English speakers

Treatment and study plan

Exparel 133 MG Per 10 ML Injection

Drug

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

Other names: Liposomal Bupivacaine

Dexamethasone

Drug

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Primary outcomes

  1. Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours

    Time frame: First 72 hours pain

    NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.

Secondary outcomes

  1. Numerical Rating Scale (NRS) Pain at Rest

    Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.

  2. Numerical Rating Scale (NRS) Pain With Movement

    Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.

  3. Opioid Consumption

    Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Opioid consumption, measured in oral morphine equivalents

  4. Patient Satisfaction With Pain Management: Scale

    Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction

  5. Brief Pain Inventory Short-form

    Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.

  6. Duration of Analgesic Block

    Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

    Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.

  7. Sensory Resolution

    Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

    Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

  8. Motor Block Resolution

    Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

    Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

  9. Time to Readiness for Discharge

    Time frame: Postanesthesia care unit (0-6 hours postoperative)

    Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.

  10. Postanesthesia Care Unit Length of Stay

    Time frame: Postanesthesia care unit (0-6 hours postoperative)

    Total length of PACU stay as defined by time of PACU admission to PACU discharge.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2019
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.