Liposomal Bupivacaine vs Dexamethasone ISB

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Exparel 133 MG Per 10 ML Injection

Dexamethasone

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal bupivacaine & standard bupivacaine

Standard bupivacaine & dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Numerical Rating Scale (NRS) Pain at Rest

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.

Numerical Rating Scale (NRS) Pain With Movement

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.

Opioid Consumption

Opioid consumption, measured in oral morphine equivalents

Patient Satisfaction With Pain Management: Scale

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

Brief Pain Inventory Short-form

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.

Duration of Analgesic Block

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.

Sensory Resolution

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

Motor Block Resolution

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

Time to Readiness for Discharge

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

Postanesthesia Care Unit Length of Stay

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

Full Information

NCT ID

NCT04047446

First Posted

July 3, 2019

Last Updated

July 7, 2022

Sponsor

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT04047446

Brief Title

Liposomal Bupivacaine vs Dexamethasone ISB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

July 11, 2019 (Actual)

Primary Completion Date

March 15, 2021 (Actual)

Study Completion Date

March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

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

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.

6. Conditions and Keywords

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

Shoulder Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposomal bupivacaine & standard bupivacaine

Arm Type

Experimental

Arm Title

Standard bupivacaine & dexamethasone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Exparel 133 MG Per 10 ML Injection

Other Intervention Name(s)

Liposomal Bupivacaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

First 72 hours pain

Secondary Outcome Measure Information:

Title

Numerical Rating Scale (NRS) Pain at Rest

Description

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.

Time Frame