Bupivacaine for Rebound Pain

(RPRCT Trial)

Overseen By Brett Elmore, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Virginia

Must not be taking: Opioids, NSAIDs

Disqualifiers: Chronic pain, Respiratory pathologies, BMI > 40, 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: 4

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different strengths of the numbing medicine bupivacaine affect pain relief after shoulder replacement surgery. Researchers aim to determine if a less concentrated dose can reduce the rebound pain often felt 24 hours post-surgery. Participants should be undergoing shoulder replacement surgery and should not have chronic pain conditions like fibromyalgia or respiratory issues like untreated sleep apnea. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Bupivacaine?

Research shows that bupivacaine is generally safe for humans when used to numb a specific area during surgery. It is commonly used to reduce pain immediately after an operation. Studies indicate that it can decrease the need for opioids, which are strong painkillers, providing a significant benefit post-surgery. However, some patients experience "rebound pain," where pain increases after the initial numbing effect fades. Reports suggest this occurs in up to 61.7% of cases.

This trial tests different strengths of bupivacaine. One group receives a stronger dose, while another receives a weaker one. The researchers compare both to determine which better manages rebound pain. Since bupivacaine is already approved for use in surgeries, its safety is well-known. However, like any medication, side effects can occur. Prospective participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Bupivacaine is unique because it offers a targeted approach to managing rebound pain with varying concentrations. Unlike traditional pain management options that often rely on opioids or other local anesthetics, this treatment explores the effects of different concentrations of bupivacaine: a concentrated 0.5% solution and a more dilute 0.25% solution. Researchers are excited about this treatment because it could provide effective pain relief while potentially reducing the risk of side effects associated with higher doses of local anesthetics. This could lead to more personalized pain management strategies, improving patient outcomes and comfort.

What evidence suggests that this trial's treatments could be effective for rebound pain?

Research has shown that bupivacaine effectively controls pain after surgery. As a local anesthetic, it numbs a specific body part to relieve pain. Studies have found that it can reduce the need for opioids, which are strong painkillers with many side effects. However, "rebound pain" often occurs when bupivacaine wears off. This trial will compare two different concentrations of bupivacaine to determine if a lower dose might lessen this rebound pain. Overall, bupivacaine is a well-known treatment for managing pain, though addressing rebound pain remains a challenge. ^{6 7 8 9 10}

Who Is on the Research Team?

Leon N Grinman, DO

Principal Investigator

UVA

Are You a Good Fit for This Trial?

This trial is for patients undergoing shoulder replacement surgery who are interested in how different doses of a local anesthetic might affect their pain after the operation. Specific eligibility details were not provided, so general health requirements and consent to participate would apply.

Inclusion Criteria

I have had a total shoulder replacement.

My gender does not affect my eligibility.

I am 18 years old or older.

Exclusion Criteria

Vulnerable populations (pregnancy, incarceration, etc)

Allergy to local anesthetics or NSAIDS

I have untreated sleep apnea or other serious lung conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive different concentrations of local anesthetic during shoulder arthroplasty

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain scores, opioid use, and other outcomes at 24, 48, and 72 hours post-operation

1 week

3 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The study is testing if lower concentrations of Bupivacaine, a local anesthetic used during shoulder surgeries, can reduce rebound pain (increased pain after initial pain relief) at 24 hours post-operation. Patients will be randomly assigned to receive varying doses.

How Is the Trial Designed?

Group I: Dilute Experimental Treatment 1 Intervention

More dilute local : 0.25% Bupivacaine

Group II: Concentrated Active Control 1 Intervention

Standard management of higher percent local anesthetic: 0.5% Bupivacaine

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7533186/

Managing rebound pain after regional anesthesia - PMC Prolonging the duration of action of regional anesthesia with continuous catheter techniques or local anesthetic adjuncts may also help alleviate rebound pain, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949962325000105

Comparing intraoperative administration of long-acting ... This study compared postoperative pain outcomes with LB versus MCs such as ropivacaine-epinephrine-clonidine-ketorolac, bupivacaine-epinephrine-dexamethasone, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07196631

Study Details | NCT07196631 | Comparison of Liposomal ... Rebound pain following the resolution of the block poses a major challenge to the effectiveness of peripheral nerve blocks for postoperative ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113170/

Rebound Pain After Regional Anaesthesia - PMC One RCT found that transauricular vagus nerve stimulation resulted in a significantly lower incidence of rebound pain compared to a sham ...

5. mdpi.com mdpi.com/2077-0383/14/3/936

Rebound Pain—Management Strategies for Transitional ... Peripheral nerve blocks (PNBs), while effective in reducing postoperative opioid use and side effects, are often associated with rebound pain (RP).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11305791/

Prevention and management of rebound pain after resolution ... It has been reported that the incidence of rebound pain could increase up to 61.7%, potentially exerting a substantial impact on patients' postoperative ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225003447

Association of peripheral nerve blocks with increased ... Peripheral nerve blocks are effective in reducing immediate postoperative pain and opioid use in orthopaedic surgeries, and potentially minimise the central ...

8. ekja.org ekja.org/journal/view.php?number=8680

Managing rebound pain after regional anesthesia Rebound pain is a transient perceptual phenomenon that occurs when the sensory blockade of RA resolves and unmasks ongoing nociceptive stimuli.

9. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2018/07/30/rebound-pain-after-a-nerve-block-wears-off

Rebound Pain After a Nerve Block Wears Off However, the patients who received the block reported increased pain 16 hours postoperatively (1.16 on a 0–10 pain scale, 99% confidence ...

10. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/117497

Liposomal Bupivacaine in Managing Postoperative Pain ... The use of LB as part of a multimodal approach to postoperative pain results in diminished use of opioids, reduced pain, and decreased length of ...