Liposomal Bupivacaine vs Dexamethasone ISB

Phase 4

Completed

• Conditions: Shoulder Pain
• Interventions: Drug: Exparel 133 MG Per 10 ML Injection; Drug: Dexamethasone

• Registration Number: NCT04047446
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study Start: 2019-07-11
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Primary Completion: 2021-03-15
• Study Completion: 2021-03-19
• Results First Submitted: 2022-05-12
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-07
• Last Update Submitted: 2022-07-07
• Results First Posted: 2022-08-01
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine & standard bupivacaine	Exparel 133 MG Per 10 ML Injection	-
Standard bupivacaine & dexamethasone	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours	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 Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) Pain at Rest	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.
Numerical Rating Scale (NRS) Pain With Movement	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.
Opioid Consumption	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
Patient Satisfaction With Pain Management: Scale	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
Motor Block Resolution	24, 48, 72, 96 (if needed) hours postoperatively	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Time to Readiness for Discharge	Postanesthesia care unit (0-6 hours postoperative)	Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
Postanesthesia Care Unit Length of Stay	Postanesthesia care unit (0-6 hours postoperative)	Total length of PACU stay as defined by time of PACU admission to PACU discharge.
Brief Pain Inventory Short-form	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.
Duration of Analgesic Block	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.
Sensory Resolution	24, 48, 72, 96 (if needed) hours postoperatively	Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States