Local Anesthetic Volume for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Benaroya Research Institute

Must not be taking: Opioids

Disqualifiers: Neuropathy, Lung disease, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.

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 data supports the effectiveness of the drug Ropivacaine (Naropin) for postoperative pain relief?

Ropivacaine is effective for managing postoperative pain, as studies show it provides pain relief similar to other local anesthetics like bupivacaine, but with fewer side effects such as motor block and toxicity. Additionally, continuous wound instillation of ropivacaine after spine surgery significantly reduced pain scores and the need for additional pain medication. ^{1 2 3 4 5}

Is ropivacaine safe for use in humans?

Ropivacaine is considered safer than bupivacaine, with less risk of heart and nervous system side effects. It has been used safely in surgeries and for pain relief after operations and childbirth. ^{1 2 6 7 8}

How is the drug ropivacaine different from other treatments for postoperative pain?

Ropivacaine is unique because it is a long-acting local anesthetic that is less likely to cause heart and nerve side effects compared to similar drugs like bupivacaine. It also tends to cause less muscle weakness, making it a safer option for managing pain after surgery. ^{1 2 9 10 11}

Research Team

Eligibility Criteria

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

You have been using opioid medication for a long time.

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

I do not have significant nerve pain or damage.

Trial Timeline

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)

Treatment Details

Interventions

• Ropivacaine (Local Anesthetic)

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.

Participant Groups

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 Canada, China for the following indications:

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. [2022]

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

Ropivacaine. [2022]

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

Continuous epidural infusion of ropivacaine for the prevention of postoperative pain after major orthopaedic surgery: a dose-finding study. [2022]

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

The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. [2022]

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

The postoperative analgesic efficacy of wound instillation with ropivacaine 0.1% versus ropivacaine 0.2%. [2022]

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

Ropivacaine: a pharmacological review. [2018]

7. Germany 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. [2021]

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

Metabolism and excretion of ropivacaine in humans. [2018]

9. Ukraine pubmed.ncbi.nlm.nih.gov

[Application of naropin (ropivacaine) for intra- and postoperative analgesia in phthysiosurgical patients]. [2018]

10. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Epidural ropivacaine for postoperative analgesia in Taiwanese patients. [2018]

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

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