Ropivacaine for Postoperative Pain

Overseen By Aaron J Deng, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Stanford University

Must not be taking: Opioids

Disqualifiers: Pregnancy, Incarceration, Neuropathy, 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: Unknown

Duration: 2-3 days

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To compare continuous infusions to bolus infusions and there affect on post-surgical pain.

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 use more than 30 mg of opioids per day, you cannot participate.

Is Ropivacaine safe for use in humans?

Ropivacaine is considered safer than bupivacaine, with less risk of heart and nervous system side effects. It is well tolerated for surgical anesthesia and pain relief after surgery, making it a good option for managing pain. ^{1 2 3 4 5}

How does the drug Ropivacaine differ from other treatments for postoperative pain?

Ropivacaine is unique because it is a pure S-enantiomer, which makes it safer with less risk of heart and nerve side effects compared to similar drugs like bupivacaine. It provides effective pain relief with less impact on muscle movement, making it a safer option for postoperative pain management. ^{1 4 5 6 7}

What data supports the effectiveness of the drug Ropivacaine for postoperative pain?

Research shows that Ropivacaine is effective for managing postoperative pain in various surgeries, including thoracotomy and craniotomy, by providing pain relief with fewer side effects compared to similar drugs like bupivacaine. ^{3 4 5 8 9}

Who Is on the Research Team?

Jean Louis-Horn, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Adult patients with good to moderate health (ASA I-III) needing nerve block catheters for pain relief after surgery can join. Excluded are those who are very overweight, use high doses of opioids, pregnant, under 18, in jail, unable to talk by phone post-op, or have pre-existing nerve issues in the surgery limb.

Inclusion Criteria

Adults who are in good to moderate health and are having nerve block catheters for pain relief after surgery can join the study.

Exclusion Criteria

You have a body mass index (BMI) greater than 35.

You take more than 30 mg of morphine or similar drugs every day before surgery.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either continuous infusion or scheduled bolus infusion of local anesthetic medication

2-3 days

Follow-up

Participants are monitored for pain levels and opioid consumption after treatment

2-3 days

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine

Trial Overview The study is testing if giving Ropivacaine continuously through an IV works better for controlling pain after surgery compared to scheduled shots. The goal is to see which method provides better pain relief and possibly reduces infection risk.

How Is the Trial Designed?

Group I: Continuous Infusion Active Control 1 Intervention

Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.

Group II: Intermittent Bolus Infusion Active Control 1 Intervention

Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.

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?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study of 77 patients undergoing cataract surgery, nine cases of symptomatic diplopia (double vision) were reported after receiving peribulbar anaesthesia with ropivicaine, indicating a previously unrecognized side effect of this anesthetic.

The diplopia observed was predominantly vertical and resolved within 30 hours, suggesting that ropivicaine may cause a temporary motor block affecting eye movement after administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diplopia from peribulbar ropivicaine. Wells, AP., Maslin, K.[2019]

In a study of 40 patients undergoing thoracotomy for esophageal cancer, wound infiltration with ropivacaine significantly reduced postoperative pain and analgesic consumption, leading to improved recovery outcomes.

Patients receiving ropivacaine experienced shorter hospital stays and earlier ambulation, with no significant side effects reported, indicating that it is a safe and effective method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine wound infiltration: a fast-track approach in patients undergoing thoracotomy surgery. Rao, Z., Zhou, H., Pan, X., et al.[2019]

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 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 50 patients undergoing supratentorial craniotomy, the use of 12 ml of 0.25% ropivacaine instilled through a surgical drain significantly reduced post-operative pain compared to a placebo (normal saline), with lower pain scores observed at multiple time points post-surgery.

The technique not only decreased pain but also resulted in a quicker emergence from anesthesia, suggesting that ropivacaine is an effective and simple method to enhance recovery in neurosurgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine instillation through subgaleal drain: A novel approach for acute post-craniotomy pain. Bala, R., Gehlaut, P., Mittal, K., 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]

Ropivacaine, compared to bupivacaine, shows a greater margin of safety in terms of systemic toxicity across different age groups, with higher doses required to induce toxicity in infants than in adults.

The duration of nerve blockade from ropivacaine is longer in infant rats than in older rats, indicating its potential effectiveness in pediatric applications, although its overall efficacy is similar to that of bupivacaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sciatic nerve blockade in infant, adolescent, and adult rats: a comparison of ropivacaine with bupivacaine. Kohane, DS., Sankar, WN., Shubina, M., et al.[2019]

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 0.2% provides effective postoperative analgesia similar to bupivacaine 0.2% in patients undergoing major lower limb orthopedic surgery, with no significant differences in onset time or duration of analgesia between the two groups.

Ropivacaine is associated with fewer adverse effects, such as motor blockade, hypotension, and nausea, compared to bupivacaine, making it a safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Epidural Analgesia Using 0.2% Bupivacaine and 0.2% Ropivacaine for the Management of Postoperative Pain in Major Orthopedic Surgery. Mehta, S., Gajbhare, MN., Kamble, NP.[2022]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Diplopia from peribulbar ropivicaine. [2019]

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

Ropivacaine wound infiltration: a fast-track approach in patients undergoing thoracotomy surgery. [2019]

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

Ropivacaine. [2022]

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

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

5. India pubmed.ncbi.nlm.nih.gov

Ropivacaine instillation through subgaleal drain: A novel approach for acute post-craniotomy pain. [2022]

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

Ropivacaine: a pharmacological review. [2018]

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

Sciatic nerve blockade in infant, adolescent, and adult rats: a comparison of ropivacaine with bupivacaine. [2019]

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

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

9. India pubmed.ncbi.nlm.nih.gov

Comparison of Epidural Analgesia Using 0.2% Bupivacaine and 0.2% Ropivacaine for the Management of Postoperative Pain in Major Orthopedic Surgery. [2022]