Pain, PostoperativePhase 4NCT05005260

Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty

A Phase 4 study testing Bupivacaine HCl and Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj in people with Pain, Postoperative and Brachial Plexus Block, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative, Brachial Plexus Block
What is being tested?: Bupivacaine HCl and Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: 14 Oct 2021to 18 Mar 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
Patients 18 years of age and older
Able to provide informed consent for him or herself

Who cannot join

Chronic pain syndromes
Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day.
Body mass index (BMI) > 45 kg/m2
Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
Personal or family history of malignant hyperthermia.
Major systemic medical problems such as:

Show all 16Show fewer

Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 93% on room air.
History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).
o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.
Known to be currently pregnant or actively breastfeeding++
o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)
Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy)
Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty

Conditions: Pain, Postoperative, Brachial Plexus Block
Being tested: Bupivacaine HCl, Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
Keywords: Interscalene nerve block, total shoulder arthroplasty, pain management, OBAS, QoR-15
Medical subject headings: Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine HClDrug
Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
Liposomal bupivacaine + Bupivacaine Hcl 0.5% InjDrug
Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).

Study groups in NCT05005260
Study group	Role	What they receive
liposomal bupivacaine single-shot interscalene blockade	Active comparator	Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine Receives: Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
continuous interscalene nerve blockade	Active comparator	Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days. Receives: Drug: Bupivacaine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity Score at Rest at 24 Hours Post-operatively
Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.
Measured: Post-Operative Day 1

Secondary outcomes (2)

Cumulative Opioid Consumption
Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3
Measured: PACU to postoperative day 3
Quality of Recovery Score (QoR)
15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: Post-Operative Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 202118 Mar 2023

First posted13 Aug 2021
Study start14 Oct 2021
Primary completion18 Mar 2023
Study completion18 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05005260
Sponsor's protocol ID: 21-000908
Status last verified: Apr 2024
First submitted: 8 Aug 2021
Last updated: 7 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty
ClinicalTrials.gov ID: NCT05005260
Acronym / sponsor ID: 21-000908
Conditions: Pain, Postoperative, Brachial Plexus Block
Keywords: Interscalene nerve block, total shoulder arthroplasty, pain management, OBAS, QoR-15
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 14 Oct 2021 (actual)
Primary completion: 18 Mar 2023 (actual)
Study completion: 18 Mar 2023 (actual)
First posted: 13 Aug 2021 (actual)
Results: Posted 18 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
liposomal bupivacaine single-shot interscalene blockade	Active comparator	Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% InjSubjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine
continuous interscalene nerve blockade	Active comparator	Drug: Bupivacaine HClSubjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).
Patients 18 years of age and older
Able to provide informed consent for him or herself

Key exclusion criteria (16 listed)

Chronic pain syndromes
Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with OME > 30 mg/day.
Body mass index (BMI) > 45 kg/m2
Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever
Personal or family history of malignant hyperthermia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine HClSubjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.	Drug	continuous interscalene nerve blockade
Liposomal bupivacaine + Bupivacaine Hcl 0.5% InjSubjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).	Drug	liposomal bupivacaine single-shot interscalene blockade

Primary outcome

Pain Intensity Score at Rest at 24 Hours Post-operatively
Time frame: Post-Operative Day 1
Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.

2 secondary outcomes

Cumulative Opioid Consumption
Time frame: PACU to postoperative day 3
Quality of Recovery Score (QoR)
Time frame: Post-Operative Day 1

Results and safety

Results posted to the registry on 18 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposomal Bupivacaine Single-shot Interscalene Blockade	42	39
Continuous Interscalene Nerve Blockade	46	44

Primary outcome: Pain Intensity Score at Rest at 24 Hours Post-operatively

Time frame: Post-Operative Day 1. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Liposomal Bupivacaine Single-shot Interscalene Blockade n = 39	Continuous Interscalene Nerve Blockade n = 44
Value	1 (0 to 3)	1 (0 to 2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First 3 days after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine Single-shot Interscalene Blockade	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Continuous Interscalene Nerve Blockade	0 of 44 (0%)	7 of 44 (15.9%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason K Panchamia, DO principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Score at Rest at 24 Hours Post-operatively (time frame: Post-Operative Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.