Pain Control for Total Shoulder Replacement

Overseen By Heinz Hoenecke, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Scripps Clinic

Must not be taking: Narcotics, Oxycodone, Celebrex

Disqualifiers: Drug abuse, Neurological deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used narcotics in the last 3 months or if you have certain allergies or intolerances.

What data supports the effectiveness of the drug Liposomal bupivacaine for pain control after total shoulder replacement?

Research shows that liposomal bupivacaine, when used in interscalene nerve blocks, helps manage pain effectively after total shoulder replacement surgery. It has been found to provide adequate pain control, with some studies indicating it may offer better pain relief compared to traditional methods. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for use in humans?

Liposomal bupivacaine (Exparel) has been shown to be safe for pain relief in surgeries like breast augmentation and reconstruction. It is approved by the FDA for certain types of pain relief, but not for use in the neuraxial space (around the spinal cord). ^{3 6 7 8 9}

How does liposomal bupivacaine differ from other drugs for pain control after total shoulder replacement?

Liposomal bupivacaine is unique because it is an extended-release form of bupivacaine that can provide pain relief for up to 72 hours after surgery, potentially reducing the need for continuous nerve block catheters and minimizing complications associated with them. ^{1 3 4 10 11}

Research Team

Heinz Hoenecke, MD

Principal Investigator

Scripps Health

Eligibility Criteria

This trial is for patients between the ages of 50 and 85 who are having their first shoulder replacement surgery. It's not suitable for those with oxycodone intolerance, conditions that make interscalene block risky, active narcotic use in the past 3 months, allergy to amide anesthetics, inability to take Celebrex, or cognitive issues affecting participation.

Inclusion Criteria

I am having a shoulder replacement or reverse shoulder surgery.

Exclusion Criteria

I am under 50 years old.

I am having a second surgery on my shoulder.

I have a neurological condition affecting my movement or senses.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo preoperative assessment including ASES score and pain score evaluation

Up to 4 weeks

1 visit (in-person)

Treatment

Participants receive interscalene block with or without liposomal bupivacaine during shoulder arthroplasty

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' narcotic and non-narcotic pain medication usage, pain severity, and satisfaction are monitored

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ASES score and pain score evaluation

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Bupivacaine
• Liposomal bupivacaine

Trial Overview The study is testing if adding liposomal bupivacaine to a standard pain blocker (interscalene block) improves pain control after shoulder replacement surgery. Patients will be randomly assigned to receive either the new combination or just the standard treatment without knowing which one they get.

Participant Groups

Group I: Study group Experimental Treatment 2 Interventions

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].

Group II: Control group Active Control 1 Intervention

The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.

Who Is Running the Clinical Trial?

Scripps Clinic

Lead Sponsor

Trials

15

Recruited

28,400+

Findings from Research

A meta-analysis of four randomized controlled trials involving 510 patients showed that liposomal bupivacaine is as effective as interscalene nerve block for managing pain after total shoulder arthroplasty, with no significant differences in pain scores or opioid consumption at 12, 24, and 48 hours post-surgery.

Both treatments provided comparable pain relief and opioid-sparing effects, suggesting that liposomal bupivacaine could be a viable alternative to traditional nerve blocks, although further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Wang, K., Zhang, HX.[2022]

In a study of 491 total shoulder arthroplasty patients, those who received liposomal bupivacaine for interscalene blocks reported significantly better pain control in the first 24 hours post-surgery, with 69% achieving clinically tolerable pain compared to only 39% in the other block group and 11% in the no block group.

Patients receiving liposomal bupivacaine also had lower average pain scores and reduced opioid consumption in the first 24 hours, indicating that it may provide effective postoperative analgesia while potentially minimizing the need for opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Interscalene Blocks Demonstrate a Greater Proportion of Total Shoulder Arthroplasty Patients with Clinically Tolerable Pain - a Retrospective Quality Improvement Study of 491 Patients. Lee, JK., Greenberg, S., Wixson, R., et al.[2023]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

In a study of 87 patients undergoing shoulder arthroplasty, local infiltration of a periarticular cocktail provided significantly better pain control immediately after surgery compared to interscalene nerve block and liposomal bupivacaine, with lower visual analog scale scores on postoperative day 0.

Patients receiving the periarticular cocktail also required significantly less opioid medication on the first day after surgery, indicating a potential for reduced opioid consumption and improved pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the use of periarticular anesthetic cocktail provide adequate pain control following shoulder arthroplasty? Klag, EA., Okoroha, KR., Kuhlmann, NA., et al.[2022]

In a study of 52 patients undergoing major shoulder surgery, the addition of liposome bupivacaine to standard bupivacaine significantly reduced worst pain levels in the first postoperative week compared to standard bupivacaine alone, with a modest effect size.

Patients receiving liposome bupivacaine also reported greater overall satisfaction with their pain management, indicating that this combination may enhance postoperative recovery experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Vandepitte, C., Kuroda, M., Witvrouw, R., et al.[2022]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

In a study of 90 patients undergoing immediate breast reconstruction, the use of liposomal bupivacaine (LB) significantly reduced postoperative pain scores compared to traditional pain management methods, indicating its efficacy as a pain reliever.

Patients receiving LB also had a shorter hospital stay (1.5 days) compared to those on narcotics (2.0 days), with no reported adverse events, highlighting its safety and potential benefits in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. Butz, DR., Shenaq, DS., Rundell, VL., et al.[2022]

In a study of 70 patients undergoing shoulder arthroplasty, liposomal bupivacaine (LB) provided effective postoperative pain relief comparable to continuous interscalene nerve block (CISB) within the first 24 hours, with similar narcotic use and pain scores.

LB was associated with better functional outcomes, as indicated by higher American Shoulder and Elbow Surgeons and Penn Shoulder Scores at follow-up, along with fewer complications and lower costs compared to the CISB group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. Sabesan, VJ., Shahriar, R., Petersen-Fitts, GR., et al.[2022]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

In a study of 565 patients undergoing total shoulder arthroplasty, liposomal bupivacaine (LB) provided significantly lower mean pain scores at 24 and 36 hours post-surgery compared to continuous interscalene catheters (CIC), indicating better postoperative pain control.

Patients receiving LB had a higher rate of opioid-free pain management (32% vs. 10%) and required less opioid escalation, suggesting that LB may reduce opioid use and associated complications in multimodal pain management for shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interscalene block with liposomal bupivacaine versus continuous interscalene catheter in primary total shoulder arthroplasty. Levin, JM., Charalambous, LT., Girden, A., et al.[2023]

In a study of 83 shoulder arthroplasty patients, the use of an indwelling interscalene nerve block (IINB) resulted in significantly lower pain scores and reduced opioid consumption immediately after surgery compared to liposomal bupivacaine (LB).

Patients receiving LB experienced higher pain levels and required more narcotics in the immediate postoperative period, indicating that IINB is a more effective pain management strategy right after shoulder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. Abildgaard, JT., Lonergan, KT., Tolan, SJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Interscalene Blocks Demonstrate a Greater Proportion of Total Shoulder Arthroplasty Patients with Clinically Tolerable Pain - a Retrospective Quality Improvement Study of 491 Patients. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Does the use of periarticular anesthetic cocktail provide adequate pain control following shoulder arthroplasty? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Interscalene block with liposomal bupivacaine versus continuous interscalene catheter in primary total shoulder arthroplasty. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. [2022]