Ropivacaine

Ropivacaine (Naropin) is a local anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain. Ropivacaine is used as a local (in only one area) anesthesia for a spinal block, also called an epidural. The medication is used to provide anesthesia during a surgery or C-section, or to ease labor pains.

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.

Ropivacaine is to be given only by or under the direct supervision of your doctor. A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins, into your upper arm, into the head and neck area, or into the space around the spinal nerves in your lower back.

Ropivacaine local anesthetic has been shown to be effective and is used widely in preventing or reducing pain from minor surgery, incisions, biopsies, dental and obstetrical procedures and pain from wounds. Ropivacaine is usually given as a single injection locally into a lesion or the area of incision, but can be given as infusions for hours or for several days by epidural or wound-based catheters. Ropivacaine local anesthetic infusions can also be used for postoperative pain management. Ropivacaine has excellent tolerance and safety. Local anesthetics have variable durations of action, and short acting versions are often given with epinephrine, which decreases the rate of absorption limiting systemic exposure and prolonging the duration of action.

Ropivacaine passes into milk poorly and is not orally absorbed by breastfed infants ¹. Infants appear not to be affected by the small amounts of drug in breast milk.

Local anesthetics administered during labor and delivery with other anesthetics and analgesics have been reported by some to interfere with breastfeeding. However, this assessment is controversial and complex because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used. Published data on the use of ropivacaine and fentanyl used during labor and delivery in a small number of women found little or no adverse effect on breastfeeding ². Labor pain medication may delay the onset of lactation.

Twenty-five infants whose mothers received a combination of ropivacaine and fentanyl for patient-controlled epidural analgesia for pain associated with cesarean section had normal Apgar and Neurological and Adaptive Capacity scores. No adverse effects were noted in any of the infants ³.

Ropivacaine mechanism of action

Ropivacaine is chemically referred to as aminoethylamides or amide local anesthetic. Ropivacaine mechanism of anesthetic action is believed to be based upon inhibition of voltage-gated sodium channels, which results in membrane stabilization and slowing of membrane depolarization and repolarization.

How is ropivacaine given?

Ropivacaine is given as an injection through a needle placed into an area of your middle or lower back near your spine. You will receive this injection in a hospital or surgical setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving ropivacaine.

Some numbing medications can have long-lasting or delayed effects. Talk to your doctor if you have concerns about this risk. Call your doctor if you have joint pain or stiffness, or weakness in any part of your body that occurs after your surgery, even months later.

Ropivacaine special precautions

It is very important that your doctor check your progress closely while you are receiving ropivacaine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Ropivacaine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you or your child has the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

If you receive Ropivacaine into your lower back (epidural), you may experience temporary loss of sensation and movement, usually in the lower half of your body. Talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ropivacaine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ropivacaine injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Pregnancy Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Ropivacaine drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving ropivacaine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ropivacaine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hyaluronidase
• Peginterferon Alfa-2b
• Pixantrone
• St John’s Wort

Using ropivacaine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin
• Fluvoxamine

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ropivacaine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems

The presence of other medical problems may affect the use of ropivacaine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.
• Heart block or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—Use with caution.
• Heart or blood vessel disease—Use with caution. The chance of side effects may be increased.
• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Ropivacaine side effects

Get emergency medical help if you have signs of an allergic reaction: hives or red skin rash; dizziness; sneezing; difficulty breathing; nausea or vomiting; sweating; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• feeling anxious, restless, confused, or like you might pass out;
• problems with speech or vision;
• ringing in the ears, metallic taste, numbness or tingling around your mouth, or tremors;
• seizure (convulsions);
• weak or shallow breathing;
• slow heart rate, weak pulse; or
• fast heart rate, gasping, feeling unusually hot.

Common side effects include:

• blurred vision
• chest pain or discomfort
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• sweating
• unusual tiredness or weakness
• nausea, vomiting;
• headache, back pain;
• fever;
• itching;
• numbness or tingly feeling; or
• problems with urination or sexual function.

Less common

• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chills
• decrease in frequency or amount of urine
• difficulty in passing urine (dribbling)
• fever
• painful urination

Rare

• absence of or decrease in body movement
• agitation
• anxiety
• bluish color of the skin or changes in skin color
• changes in vision
• clumsiness
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• decreased awareness or responsiveness
• difficulty breathing
• drooping upper eyelids
• drowsiness
• fast or irregular heartbeat
• general feeling of discomfort or illness
• hearing loss
• loss of appetite
• loss of consciousness
• low body temperature
• mood or mental changes
• muscle aches
• muscle spasms (tetany) or twitching seizures
• muscle weakness
• nausea
• nervousness
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• problems with memory
• seeing or hearing things that are not there
• seizures
• severe sleepiness
• severe, unusual tiredness or weakness
• shivering
• slow heartbeat
• swelling of the foot or leg tenderness
• tightness in the chest
• trembling
• trouble sleeping
• vomiting
• weak or feeble pulse
• weight gain
• yellow skin or eyes

Incidence not known

• anxiety
• depression
• difficulty swallowing
• excitation
• fast, irregular, pounding, or racing heartbeat or pulse
• hives, itching, skin rash
• inability to breathe without assistance
• paralysis of the arms
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• slow heartbeat
• tremors

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

References

1. Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Ropivacaine. [Updated 2018 Oct 31]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501506
2. (French CA, Cong X, Chung KS. Labor epidural analgesia and breastfeeding: A systematic review. J Hum Lact. 2016;32:507-20.
3. Matsota PK, Markantonis SL, Fousteri MZ et al. Excretion of ropivacaine in breast milk during patient-controlled epidural analgesia after cesarean delivery. Reg Anesth Pain Med. 2009;34:126-9.