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Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT03728946
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Paul Sethi, Orthopaedic & Neurosurgery Specialists

Brief Summary:
The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Postoperative Pain Drug: Liposomal Bupivacaine Not Applicable

Detailed Description:

Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.

The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposomal Bupivacaine Interscalene Block
Liposomal bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.
Drug: Liposomal Bupivacaine
Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
Other Name: EXPAREL

No Intervention: Bupivacaine Interscalene Block
Bupivacaine anesthetic will be administered as an interscalene block during rotator cuff repair surgery and total shoulder arthroplasty.



Primary Outcome Measures :
  1. Opiate Consumption [ Time Frame: Post-operative days 1-14 ]
    Total amount of narcotics consumed during the postoperative period, measured in morphine equivalents (OME)


Secondary Outcome Measures :
  1. VAS Pain Scores [ Time Frame: Post operative days 1-14 ]
    A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively

  2. Likert Pain Satisfaction Rating [ Time Frame: Post operative days 1-14 ]
    A standardized measure of patient satisfaction with pain management from 1 (very unsatisfied) to 5 (very satisfied)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

  • Pregnant
  • Documented drug of alcohol abuse
  • Active narcotic use prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Not cleared by primary care physician
  • Hydrocodone or oxycodone intolerance
  • Enrollment in another clinical trial or past cognitive or mental health status that interferes with study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728946


Locations
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United States, Connecticut
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Orthopaedic & Neurosurgery Specialists
Greenwich, Connecticut, United States, 06831
Stamford Ambulatory Surgical Center
Stamford, Connecticut, United States, 06902
United States, Florida
Atlantis Orthopaedics
Atlantis, Florida, United States, 06831
Atlantis Orthopaedics
Palm Beach Gardens, Florida, United States, 33410
United States, Oregon
Southern Oregon Orthopedics, Inc.
Medford, Oregon, United States, 97504
Sponsors and Collaborators
Orthopaedic & Neurosurgery Specialists
Publications:

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Responsible Party: Paul Sethi, Principal Investigator, Orthopaedic & Neurosurgery Specialists
ClinicalTrials.gov Identifier: NCT03728946    
Other Study ID Numbers: 2018016
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents