Local Anesthetic Volume for Postoperative Pain

Overseen By David Auyong

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Benaroya Research Institute

Must not be taking: Opioids

Disqualifiers: Neuropathy, Lung disease, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different volumes of the local anesthetic ropivacaine (also known as Naropin) can manage pain after shoulder surgery. The goal is to determine the optimal amount that effectively reduces pain without causing lung issues. Participants will receive one of three types of nerve blocks to numb the shoulder area. Candidates may qualify if they are undergoing shoulder surgery, have no lung problems, and are not allergic to ropivacaine. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using chronic opioids, you would not be eligible to participate.

What is the safety track record for Ropivacaine?

Previous studies have safely used ropivacaine for various brachial plexus nerve blocks. Reports on the interscalene approach indicate that while it can occasionally cause issues like nerve injury or breathing problems, these are uncommon. Using the correct amount of ropivacaine is crucial to minimize these risks. Studies have shown that moderate amounts, such as 0.75%, are effective and safer for pain relief.

For suprascapular and supraclavicular approaches, ropivacaine is also considered safe. Research on these methods shows that patients typically tolerate the drug well, experiencing only minor side effects like nausea. It provides effective pain relief and has a reliable safety record. Additionally, using ultrasound during these procedures can enhance safety by helping doctors place the anesthetic accurately.

This trial involves ropivacaine, which has a strong safety record based on past research. Discussing any concerns with a healthcare provider is important to understand what to expect during participation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about exploring different volumes of ropivacaine for postoperative pain management because it could lead to more effective and tailored pain relief. Unlike other local anesthetics, ropivacaine is known for providing long-lasting pain control with less potential for nerve damage and systemic toxicity. This trial is investigating its use in three different types of brachial plexus blocks: interscalene, suprascapular, and supraclavicular, which target specific nerves to potentially optimize pain management for different surgical sites. By fine-tuning the volume used in these blocks, the study aims to enhance recovery and comfort for patients after surgery.

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

This trial will compare the effectiveness of ropivacaine in different types of brachial plexus blocks for managing postoperative pain. Research has shown that ropivacaine effectively manages pain after surgery when used in certain nerve blocks around the shoulder. Specifically, participants in this trial may receive ropivacaine in interscalene blocks, which has been shown to control pain after surgery and reduce opioid use. Other participants may receive suprascapular nerve blocks with ropivacaine, which provide good pain relief, especially when combined with other nerve blocks. Additionally, supraclavicular blocks with ropivacaine are safe and effective, offering long-lasting pain relief. Overall, ropivacaine is a reliable choice for managing pain in various nerve blocks around the shoulder. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need arthroscopic rotator cuff surgery, have a BMI under 40, and are generally healthy (ASA I-III). It's not for those with site infections, limb restrictions due to medical history, severe lung disease, ropivacaine allergy, neuropathy, chronic opioid use or if they can't consent in English.

Inclusion Criteria

I am eligible for keyhole surgery on my shoulder.

You weigh less than 40 kilograms for every square meter of your height.

You have a low to moderate risk for surgical complications based on your overall health.

Exclusion Criteria

I have limited movement in my limbs due to past health issues.

You have been using opioid medication for a long time.

I do not have significant nerve pain or damage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brachial plexus block using a continuous reassessment method to determine the optimal local anesthetic volume for pain relief during arthroscopic rotator cuff shoulder surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for block success and side effects, including lung function and other secondary outcomes, 60 minutes after surgery

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine

Trial Overview

The study tests the optimal dose of Ropivacaine (0.5%) for pain relief after shoulder surgery using brachial plexus block. It's a forward-looking study that blinds patients to treatment and uses an innovative method to assess both success rates and potential side effects like lung dysfunction.

How Is the Trial Designed?

Group I: Brachial Plexus Group 3 Experimental Treatment 1 Intervention

Suprascapular

Group II: Brachial Plexus Group 2 Experimental Treatment 1 Intervention

Supraclavicular

Group III: Brachial Plexus Block Group 1 Experimental Treatment 1 Intervention

Interscalene

Ropivacaine is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in United States as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in Canada as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in China as Naropin for:

• Surgical anesthesia
• Pain relief

Who Is Running the Clinical Trial?

Benaroya Research Institute

Lead Sponsor

Trials

50

Recruited

12,300+

Published Research Related to This Trial

Using the local anesthetic naropin (ropivacaine) for pain management in phthysiosurgical patients allowed for a 50% reduction in the required dose of opioid analgesics.

The use of naropin facilitated early mobilization in 50-70% of patients and decreased postoperative complications related to the respiratory and digestive systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of naropin (ropivacaine) for intra- and postoperative analgesia in phthysiosurgical patients]. Opanasenko, NS., Obremskaia, OK., Klimenko, VI., et al.[2018]

Ropivacaine, a local anesthetic, was primarily eliminated through urine, with 86% of the administered dose recovered in urine and only 1% excreted unchanged, indicating extensive metabolism.

The study found that the maximum plasma concentration of ropivacaine was 5.9 microM with an elimination half-life of about 2 hours, suggesting a relatively quick clearance from the body after intravenous administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolism and excretion of ropivacaine in humans. Halldin, MM., Bredberg, E., Angelin, B., et al.[2018]

Ropivacaine, a long-acting local anesthetic, is safer than bupivacaine, showing less cardiovascular and central nervous system toxicity, making it a preferable option for various types of anesthesia.

While ropivacaine provides similar sensory block effects as bupivacaine, it causes less motor block, which may be beneficial in certain surgical situations, although its higher cost could limit its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine. Owen, MD., Dean, LS.[2022]

Ropivacaine is a long-acting local anesthetic that has been shown to have a better safety profile than bupivacaine, particularly with reduced cardiovascular toxicity, making it a safer option for various medical procedures.

It is equally effective as bupivacaine for different types of anesthesia, such as epidural and nerve blocks, but causes less motor block, which is beneficial in settings like obstetrics and pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a pharmacological review. Hansen, TG.[2018]

In a study involving 88 patients undergoing hip surgery, 0.5% levobupivacaine demonstrated equivalent efficacy to 0.5% bupivacaine and 0.75% ropivacaine for epidural anesthesia, showing similar onset and offset times for sensory and motor block.

While levobupivacaine required a higher demand for intraoperative anesthesia, there were no significant differences in postoperative pain relief or safety parameters compared to the other anesthetics, confirming its effectiveness as an alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery: a multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine. Koch, T., Fichtner, A., Schwemmer, U., et al.[2021]

In a study of 44 patients undergoing major orthopedic surgery, continuous epidural infusions of ropivacaine at concentrations of 0.1%, 0.2%, and 0.3% significantly improved postoperative pain relief and reduced the need for morphine compared to a saline control.

The 0.1% and 0.2% concentrations provided effective sensory anesthesia with less motor blockade than the 0.3% concentration, suggesting a balance between pain relief and maintaining motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous epidural infusion of ropivacaine for the prevention of postoperative pain after major orthopaedic surgery: a dose-finding study. Badner, NH., Reid, D., Sullivan, P., et al.[2022]

In a study of 38 patients undergoing spine stabilization surgery, continuous wound instillation of ropivacaine significantly reduced pain scores and the need for additional pain medication compared to standard IV morphine and ketorolac treatment.

The use of ropivacaine not only improved pain management but also resulted in less postoperative blood loss and a shorter hospital stay, with no observed toxic side effects, indicating its safety and efficacy for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Bianconi, M., Ferraro, L., Ricci, R., et al.[2022]

In a study involving 40 patients undergoing total abdominal hysterectomy, varying the concentration of ropivacaine (0.1% vs. 0.2%) for postoperative pain relief did not significantly impact pain scores or the amount of rescue morphine needed.

Both groups required similar amounts of rescue medication and had comparable pain management outcomes, indicating that the concentration of ropivacaine does not influence the effectiveness of wound instillation analgesia in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The postoperative analgesic efficacy of wound instillation with ropivacaine 0.1% versus ropivacaine 0.2%. Zohar, E., Shapiro, A., Phillipov, A., et al.[2022]

Ropivacaine is a long-acting local anesthetic that effectively blocks nerve signals by inhibiting sodium ion influx, making it suitable for surgical anesthesia and pain relief during and after surgery.

Compared to bupivacaine, ropivacaine has a similar efficacy for nerve blocks but is associated with a lower risk of motor block and reduced potential for central nervous system and cardiac toxicity, making it a safer option for regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. Simpson, D., Curran, MP., Oldfield, V., et al.[2022]

In a study of 105 Taiwanese patients, 0.125% ropivacaine provided effective postoperative analgesia with a visual analogue scale (VAS) score of 3.11, which was comparable to the higher 0.15% dosage, but with fewer adverse effects.

The study suggests that 0.125% ropivacaine is a suitable dosage for postoperative pain management in Taiwanese patients, as it resulted in less incidence of side effects like paraesthesia, nausea, and urinary retention compared to the higher dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural ropivacaine for postoperative analgesia in Taiwanese patients. Lee, WK., Li, CH., Lee, LS., et al.[2018]

Ropivacaine, a long-acting local anesthetic, was effectively used in eight patients for various oral surgeries, providing sufficient anesthesia and analgesia during procedures.

Postoperative pain relief lasted up to 380 minutes without any reported side effects or local reactions, indicating its safety and efficacy for dental applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The assessment of anesthetic efficacy of ropivacaine in oral surgery. Buric, N.[2018]

Citations

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pubmed.ncbi.nlm.nih.gov

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Comparison between two different concentrations of a fixed ...

Conclusion: Compared with 10 ml of 0.75% ropivacaine, interscalene block with 20 ml of 0.375% ropivacaine could be effective for the reduction ...

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Median Effective Analgesic Concentration of Ropivacaine ...

With regard to proximal humerus fracture operation, ISBPB is effective in postoperative pain control and reducing opiate intraoperative use in ...

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sciencedirect.com

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This study showed no difference in pain control or respiratory function between interscalene CPNBH with 0.125% bupivacaine and 0.2% ropivacaine. These are the ...

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jsesinternational.org

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Drug-dependent analgesic efficacy in interscalene block ...

ISB with levobupivacaine and dexamethasone can provide more effective postoperative pain control after ARCR than ropivacaine and dexamethasone.

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Results: The degree of shoulder analgesia was dose dependent. Postoperative pain scores were lowest with 0.5% ropivacaine, and analgesic was not required in the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7139877/

Patient Complications after Interscalene Block

Complications of ISBs include brachial plexus injury, nerve damage, local anesthetic systemic toxicity, Horner's syndrome, and phrenic nerve paralysis [12–15].

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091224007529

Respiratory impact of local anaesthetic volume after ...

The optimal local anaesthetic volume balancing safety and efficacy in extrafascial interscalene brachial plexus block is unclear. •. In this study, reducing ...

8.

frontiersin.org

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Optimal concentration of ropivacaine for brachial plexus ...

In summary, moderate-quality evidence suggested that 0.75% ropivacaine is a better choice for brachial nerve blockade in adult patients during ...

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Comparison Study of Bupivacaine and Ropivacaine for ...

A Retrospective Analysis of the. Analgesic and Adverse Effects of Interscalene Brachial Plexus Block. During Arthroscopic Shoulder Surgery.

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The Impact of Brachial Plexus Block with Different ...

Both 0.2% and 0.5% ropivacaine had similar effects in improving postoperative pain. There were no serious block-related complications in either ...