Liposomal Bupivacaine vs Dexamethasone ISB

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047446
• Other study ID #: 2019-0424
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2019
• Est. completion date: March 19, 2021

Study information

• Verified date: July 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 19, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Drug:
• Exparel 133 MG Per 10 ML Injection
10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
• Dexamethasone
15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First 72 hours pain
Secondary	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.	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Secondary	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.	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Secondary	Opioid Consumption	Opioid consumption, measured in oral morphine equivalents	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Secondary	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	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Secondary	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.	Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Secondary	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.	24, 48, 72, 96 (if needed) hours postoperatively
Secondary	Sensory Resolution	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.	24, 48, 72, 96 (if needed) hours postoperatively
Secondary	Motor Block Resolution	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.	24, 48, 72, 96 (if needed) hours postoperatively
Secondary	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 (0-6 hours postoperative)
Secondary	Postanesthesia Care Unit Length of Stay	Total length of PACU stay as defined by time of PACU admission to PACU discharge.	Postanesthesia care unit (0-6 hours postoperative)