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?

This trial tests the effectiveness of two methods of administering the pain relief medicine Ropivacaine, a local anesthetic, after surgery. One method delivers a steady, continuous flow, while the other provides scheduled bursts. The goal is to determine which method better manages post-surgery pain. It suits adults scheduled to receive nerve block catheters for pain relief after surgery. As a Phase 4 trial, this research aims to understand how an 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 use more than 30 mg of opioids per day, you cannot participate.

What is the safety track record for Ropivacaine?

Research shows that ropivacaine is generally safe for adults when used to relieve pain after surgery. Studies indicate that taking up to 800 mg over 24 hours is usually safe. For continuous use, doses up to 28 mg per hour for 72 hours have been well tolerated, meaning the medicine didn't cause major problems for most people.

However, some side effects may occur. Common ones include low blood pressure, nausea, vomiting, slow heart rate, fever, and headache, reported by at least 5% of people using ropivacaine.

Overall, evidence suggests that ropivacaine is safe for managing pain after surgery, whether given continuously or in scheduled doses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain because they offer a unique approach to pain management compared to standard options like opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Unlike traditional methods, which can have significant side effects, Ropivacaine is a local anesthetic that minimizes pain by blocking nerve signals directly at the source. The trial explores two delivery methods: Continuous Infusion, providing a steady rate of medication, and Intermittent Bolus Infusion, which administers medication in scheduled doses. These methods aim to optimize pain relief while reducing the risk of systemic side effects, offering a potentially safer and more effective alternative for patients recovering from surgery.

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

Studies have shown that ropivacaine effectively reduces pain after surgery. In this trial, participants will receive ropivacaine either through continuous infusion or intermittent bolus infusion. A continuous flow of ropivacaine provides strong pain relief, speeds recovery, and reduces the need for opioids, which are strong pain medicines with potential side effects. Alternatively, administering ropivacaine in separate doses, known as intermittent bolus infusion, is also effective. Some research indicates it reduces the need for other pain medicines like tramadol. Both methods—continuous and intermittent—manage pain well after surgery, but they work differently and may offer distinct benefits. This treatment is already approved for use, demonstrating its effectiveness for pain management. ^{6 7 8 9 10}

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

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, 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]

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, 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 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]

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]

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 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 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.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091217341065

Pain Effectiveness of continuous wound infusion of 0.5% ...

Continuous surgical wound infusion with ropivacaine improved pain relief and accelerated recovery and discharge reducing overall costs of care.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7480288/

Continuous preperitoneal infusion of ropivacaine for ...

Continuous preperitoneal infusion provides a superior analgesic effect than the continuous epidural infusion as regards delayed first request of analgesia.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03349034

Local Infusion of Ropivacaine for Post-Op Pain Control ...

Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405844024156393

Efficacy of continuous preperitoneal ropivacaine infusion in ...

This study evaluated the efficacy of local continuous subfascial infusion of ropivacaine in relieving postoperative pain and reducing opioid requirements

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4483959/

Postoperative continuous wound infusion of ropivacaine ...

Conclusion: Continuous wound infusion with ropivacaine is effective for postoperative analgesia and has comparable effects to traditional PCA with sufentanil.

6.

medsafe.govt.nz

medsafe.govt.nz/profs/datasheet/n/Naropininj.pdf

DATA SHEET

Cumulative doses up to 800 mg ropivacaine for surgery and post operative analgesia administered over 24 hours were well tolerated in adults, as were ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf

Naropin® (ropivacaine HCl) Injection - accessdata.fda.gov

Continuous epidural infusion of Naropin 2 mg/mL (0.2%) during up to 72 hours for postoperative pain management after major abdominal surgery was studied in 2.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17304151/

Safety of 96-hour incision-site continuous infusion ...

The aim of this study was to examine the safety of ropivacaine given to patients as a continuous infusion [0.2% (2 mg/mL), 5 mL/h for 96 hours] into a right ...

9.

naropin-us.com

naropin-us.com/clinical-information/dosing-information/

NAROPIN Dosing

Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults; ie, 2016 mg plus surgical dose of approximately 100– ...

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1600613522277818

Efficacy and Safety of Continuous Local Infusion ...

CILA with 0.5% ropivacaine provides effective postoperative pain relief, reduces the need for opioid treatment and promotes postoperative recovery. Previous ...