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Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Primary Purpose

Arthropathy Shoulder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivacaine
Bupivacaine Hydrochloride
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy Shoulder

Eligibility Criteria

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

Inclusion Criteria

  • All adult patients (>18 years of age)
  • Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy
  • Cognitively intact with the ability to give informed consent as outlined by our institutional review board.
  • Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events

Exclusion Criteria

  • Non-elective cases
  • Infection, tumor, trauma
  • Weight < 50 kg
  • Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics
  • Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl
  • Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively
  • Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder)
  • Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests.
  • Pregnancy
  • Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence)

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal Bupivacaine

Plain Bupivacaine

Arm Description

Administered utilizing ultrasound guidance by an anesthesiologist. Study patients will receive 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.

Peripheral nerve blocks will be performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride will be utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block will be utilized. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.

Outcomes

Primary Outcome Measures

Patient Pain Scores
Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.

Secondary Outcome Measures

Opioid Consumption
Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Time to Cessation of Nerve Blockade
Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Satisfaction With Pain Control Using Satisfaction Scale
Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.

Full Information

First Posted
September 4, 2018
Last Updated
February 15, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03663283
Brief Title
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Official Title
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.
Detailed Description
This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The pharmacist will prepare, and dispense the medication sequentially. Medication syringes will be blinded utilizing black tape. Patients, care team in recovery, study team members collecting and recording data, and statisticians will be blinded to randomization assignment. All patients will be documented in EMR as receiving liposomal bupivacaine to ensure the blind is maintained and to ensure that safety features in the EMR for all patients receiving liposomal bupivacaine are activated. Further, all additional standard precautionary measures (e.g. wrist band) will be similarly implemented for both patient groups.
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Administered utilizing ultrasound guidance by an anesthesiologist. Study patients will receive 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.
Arm Title
Plain Bupivacaine
Arm Type
Active Comparator
Arm Description
Peripheral nerve blocks will be performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride will be utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block will be utilized. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
Interscalene Nerve Blocks
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Interscalene Nerve Blocks
Primary Outcome Measure Information:
Title
Patient Pain Scores
Description
Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.
Time Frame
72 hours post-operatively
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks
Time Frame
Measured at 72 hours and at 3 weeks post-operatively
Title
Time to Cessation of Nerve Blockade
Description
Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.
Time Frame
4, 8, 12, 16, 20, 24, and 28 hours post-operatively
Title
Satisfaction With Pain Control Using Satisfaction Scale
Description
Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.
Time Frame
Measured at 72 hours and at three weeks post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria All adult patients (>18 years of age) Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy Cognitively intact with the ability to give informed consent as outlined by our institutional review board. Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events Exclusion Criteria Non-elective cases Infection, tumor, trauma Weight < 50 kg Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder) Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests. Pregnancy Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Hattrup
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
URL
https://pubmed.ncbi.nlm.nih.gov/33045330/
Description
PubMed

Learn more about this trial

Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

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