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Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663283
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Steven J. Hattrup, MD, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Arthropathy Shoulder Drug: Liposomal Bupivacaine Drug: Bupivacaine Hydrochloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposomal Bupivacaine
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.
Drug: Liposomal Bupivacaine
Interscalene Nerve Blocks

Active Comparator: Control Group
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.
Drug: Bupivacaine Hydrochloride
Interscalene Nerve Blocks




Primary Outcome Measures :
  1. Mean difference in patient pain scores [ Time Frame: 72 hours post-operatively ]
    Mean difference in patient pain scores over the first 72 hours post-operatively between two groups using the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.


Secondary Outcome Measures :
  1. Total opioid consumption [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks

  2. Duration of block [ Time Frame: 72 hours post-operatively ]
    Patient perceived duration of block determined as the time patient perceives complete resolution of block

  3. Satisfaction with pain control using Satisfaction Scale [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    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.

  4. Satisfaction with pain control using Patient Reported Outcomes Survey Modified American Shoulder and Elbow Surgeon's Rating Scale [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    Patient reported outcome measures using Modified American Shoulder and Elbow Surgeon's Rating Scale at 72 hours post operatively 3 weeks post-operatively

  5. Satisfaction with pain control using Patient Reported Outcomes Survey Single Assessment Numeric Evaluation [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    Patient reported outcome measures using Single Assessment Numeric Evaluation at 72 hours post operatively 3 weeks post-operatively

  6. Satisfaction with pain control using Patient Reported Outcomes Survey Simple Shoulder Test [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    Patient reported outcome measures using Simple Shoulder Test at 72 hours post operatively 3 weeks post-operatively

  7. Satisfaction with pain control using Patient Reported Outcomes Survey Veteran RAND 12 Item Health Survey [ Time Frame: Measured at 72 hours and at three weeks post-operatively ]
    Patient reported outcome measures using Veteran RAND 12 Item Health Survey at 72 hours post operatively 3 weeks post-operatively



Information from the National Library of Medicine

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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

  • 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)

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): NCT03663283


Locations
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United States, Arizona
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Steven J Hattrup Mayo Clinic
Additional Information:
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Responsible Party: Steven J. Hattrup, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03663283    
Other Study ID Numbers: 18-005366
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents