Single-injection bupivacaine HCl plus liposomal bupivacaine for Shoulder Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TX
Shoulder Pain
Single-injection bupivacaine HCl plus liposomal bupivacaine - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Shoulder Pain

Study Summary

This study is evaluating whether a single injection of bupivacaine HCl plus liposomal bupivacaine is more effective than a single injection of bupivacaine HCl alone for pain control after shoulder arthroscopy.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Single-injection bupivacaine HCl plus liposomal bupivacaine will improve 1 primary outcome and 1 secondary outcome in patients with Shoulder Pain. Measurement will happen over the course of 24 hours.

24 hours
Median pain score on POD1
72 hours
Cumulative Area under Curve median pain score on POD1-3

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Bupivacaine HCl/Bupivacaine CISB
Liposomal Bupivacaine Added to Interscalene Block

This trial requires 46 total participants across 2 different treatment groups

This trial involves 2 different treatments. Single-injection Bupivacaine HCl Plus Liposomal Bupivacaine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Liposomal Bupivacaine Added to Interscalene Block
Procedure
23 patients will be enrolled to receive a single-injection bupivacaine HCl interscalene block with liposomal bupivacaine added to same injection.
Bupivacaine HCl/Bupivacaine CISB
Procedure
23 patients will be enrolled to receive a single-injection bupivacaine HCL interscalene block with bupivacaine CISB added.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 72 hours for reporting.

Who is running the study

Principal Investigator
A. M.
Prof. Anthony Machi, Assistant Professor
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals presenting for major shoulder arthroscopy procedures at Ambulatory Services Center (Outpatient Surgery Center) -that include rotator cuff repair and biceps tenodesis
Patient is able to provide informed consent to participate in the study.
Adult patients ≥ 18 years

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is shoulder pain?

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Shoulder pain is often related to degenerative diseases—specifically, osteoarthritis and/or some shoulder dysturbility. Rarely, there may be serious blood vessel or nerve problems near the shoulder. But most often, shoulder pain is a result of a small musculoligament injury from a hard-hard fall—such as being struck by a blunt object. This article introduces the shoulder and its many related disorders. It examines the causes and treatments for shoulder pain. It also describes the different signs of shoulder problems and examines the diagnosis of shoulder pain.

Unverified Answer

How many people get shoulder pain a year in the United States?

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About 35 million people suffer from persistent pain in their shoulders each year in the United States. Patients with shoulder pain, however, are often undertreated.

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What are the signs of shoulder pain?

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Symptoms of shoulder pain may be mild, moderate or severe. They may include inability to raise the scapula or pain around the shoulder region. Signs involve the rotator cuff. They can include lack of strength and range of movement, weakness in raising shoulder from the side or pain along the shoulder. The diagnosis is often made using symptoms along with physical examination and imaging studies. The shoulder pain is caused by tendonitis in 10-30% of people after several weeks of shoulder pain. In this group, signs include lack of range of motion and inability to do things such as pull up the arm from the side. There may be tenderness over the biceps and subscapularis. Diagnosis is confirmed using imaging studies of the shoulder.

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Can shoulder pain be cured?

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A comprehensive approach to treating cervical shoulder pain should be tailored to each patient. Surgical interventions are effective for treating patients with disabling pain to achieve a cure rate of 80-90%.

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What causes shoulder pain?

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Results from a recent paper suggests that shoulder pain following an elbow injury is related to the presence of a rotator cuff tear. The presence of a tear could explain pain with passive shoulder extension, particularly if there is rotator cuff fatty infiltration which can reduce the rotator cuff's ability to retain the humeral head in the glenoid cavity. Furthermore, shoulder pain may also result from overuse injury such as impingement or overscenario.

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What are common treatments for shoulder pain?

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There are many effective treatments for shoulder pain. The first step in treating shoulder pain is knowing basic facts like the pain's cause, age, and severity. After knowing these facts, consults [with your physicians/other healthcare providers] to see if it is a more efficient way to spend your healthcare resources. Doctors/other healthcare providers may be able to recommend treatments for your current shoulder pain or may provide alternative treatments. There is not one treatment that works for all people, and some treatments may not work for people under certain conditions. For more information about treatment for shoulder pain, visit the [Wonner Pain Inventory website for the most up-to-date guide.

Unverified Answer

What does single-injection bupivacaine hcl plus liposomal bupivacaine usually treat?

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Single-injection LA plus LB seems to be effective in providing pain relief following arthroscopic shoulder surgery. It may be a useful option for patients with minimal discomfort because of the low-volume local anesthetic content.

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Have there been any new discoveries for treating shoulder pain?

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With current knowledge and treatment, shoulder pain in the general population is quite good at self-manageing and not going to need any of the treatments described here. However, in those subjects who have pain and stiffness, they will most probably benefit from therapy. Further research is needed to understand shoulder pain in order to develop more reliable treatments and to understand pain mechanisms as well as how to target them in order to get the most benefit.

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What is the latest research for shoulder pain?

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There is currently no single optimal research tool, intervention, or set of interventions for chronic musculoskeletal shoulder pain. Furthermore, evidence suggests that different therapeutic interventions may be used for different patients within the same treatment group. Continued research into individualized treatment will help reduce both short- and long-term symptoms associated with shoulder pain.

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What is the average age someone gets shoulder pain?

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The average age of onset of shoulder pain is 50 years. It has been observed in all occupational groups, and has not increased in recent decades.

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Does single-injection bupivacaine hcl plus liposomal bupivacaine improve quality of life for those with shoulder pain?

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Single-injection HA combined with liposomal bupivacaine provides superior pain relief compared with HA alone. Participants treated with HA + LA showed significant superiority over all other treatments.

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What are the latest developments in single-injection bupivacaine hcl plus liposomal bupivacaine for therapeutic use?

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Bupivacaine is a first-choice local anesthetic and its usage is well documented in pain management. While its availability on the Iranian market remains limited, a combination of a single-injection hcl bupivacaine with a liposomal encapsulation offers a new and desirable approach to pain management in the regional analgesic area.

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