Ropivacaine Hydrochloride injection is a long-acting anesthetic drug that is used in the management of acute pain syndromes and for regional/ surgical anesthesia.

Ropivacaine Uses:

• Acute pain management:

  • For acute pain management administered as an epidural continuous infusion, intermittent bolus (eg, postoperative or labor), or local infiltration.

• Surgical anesthesia:

  • For local or regional anesthesia for surgery administered as an epidural block, including cesarean section, major nerve block, or local infiltration.

Ropivacaine Dose in Adults:

Dose varies with procedure, onset and depth of anesthesia desired, vascularity of tissues, duration of anesthesia, and condition of patient. A test dose of short-acting local anesthestic containing epinephrine (eg, 3 to 5 mL) should be administered prior to induction of complete block with ropivacaine. Incremental ropivacaine dosing is recommended.

Ropivacaine Dose in the treatment of Surgical anesthesia:

• Lumbar epidural block for surgery:

  • 15 to 30 mL of 0.5% solution
  • 15 to 25 mL of 0.75% solution
  • 15 to 20 mL of 1% solution

• Lumbar epidural block for cesarean section:

  • 20 to 30 mL dose of 0.5% solution
  • 15 to 20 mL dose of 0.75% solution

• Thoracic epidural block:

  • 5 to 15 mL dose of 0.5% solution
  • 5 to 15 mL dose of 0.75% solution

• Major nerve block:

  • 35 to 50 mL dose of 0.5% solution
  • 10 to 40 mL dose of 0.75% solution

• Field block:

  • 1 to 40 mL dose of 0.5% solution

Ropivacaine Dose in the treatment of Labor pain management:

• Lumbar epidural:

  • Initial: 10 to 20 mL 0.2% solution;
  • continuous infusion dose: 6 to 14 mL/hour of 0.2% solution with incremental injections of 10 to 15 mL/hour of 0.2% solution

Ropivacaine Dose in the treatment of Postoperative pain management:

• Peripheral nerve block:

  • Continuous infusion dose: 5 to 10 mL/hour of 0.2% solution.

• Lumbar or thoracic epidural:

  • Continuous infusion dose: 6 to 14 mL/hour of 0.2% solution

• Infiltration/minor nerve block:

  • 1 to 100 mL dose of 0.2% solution
  • 1 to 40 mL dose of 0.5% solution

Ropivacaine Dose in Children:

Note:

• Dose is variable according to procedure, depth of anesthesia, vascularity of tissues, duration of anesthesia, and condition of patient.
• Consider incremental administration with negative aspiration before each injection; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
• Should only be administered under the supervision of a qualified physician experienced in the use of anesthetics. Dosing units variable (mL/kg, mg/kg);
• use extra precaution to ensure accuracy and minimize potential toxicity.

Ropivacaine Dose in the treatment of Central nerve blocks/anesthesia (eg, caudal, lumbar, thoracic): Limited data available:

• Caudal block:

  • Infants and Children:

    • Caudal injection: 0.2% (2 mg/mL) solution:
      • 0.5 to 1 mL/kg;
    • some experts suggest a maximum volume of 25 mL.

• Epidural block (eg, lumbar, thoracic):

  • Infants, Children, and Adolescents:

    • Epidural injection 0.2% (2 mg/mL): 0.7 mL/kg.

Note:

• For infants if repeat injections necessary, a decreased dose may be required to prevent drug accumulation.
• Some experts suggest if at least 45 minutes since first dose, reduce dose to / of the initial or if at least 90 minutes since first dose, then reduce dose to half of the initial.
• If additional doses are necessary, doses should be reduced to half of the previous dose.

• Epidural Block, continuous infusion:

  • Infants <3 months:

    • Epidural injection: Bolus:
      • Usual concentration 0.2% (2 mg/mL) solution:
        • Reported range: 0.5 to 1 mL/kg.
        • In some cases, a more dilute solution (eg, 0.1% [1 mg/mL]) may be needed to ensure adequate volume and minimize toxicity.
        • Follow with continuous epidural infusion of 0.2% (2 mg/mL) solution at 0.2 mg/kg/hour.

  • Infants ≥3 months, Children, and Adolescents:

    • Epidural injection: 0.2% (2 mg/mL) solution: Bolus:
      • Reported range: 0.5 to 1 mL/kg administered over several minutes (eg, 3 to 5 minutes) follow with continuous epidural infusion at 0.4 mg/kg/hour;
      • in adults, usual rates are 6 to 14 mL/hour of 0.2% solution.

Ropivacaine Dose in the treatment of Peripheral nerve blocks/ local anesthesia: Limited data available:

Note: Dose varies with location of block (ie, procedure), depth of anesthesia, vascularity of tissues, duration of anesthesia, and patient parameters (eg, age, weight, condition). Single injection:

• The volume of dose (mL/kg) and concentration of solution are  based upon site, anatomy and variable among patients and procedure.

• Infants ≥6 months, Children, and Adolescents:

  • Suggested or reported dose volumes presented; not to exceed a suggested maximum dose of 3 mg/kg/dose based on lean body mass; additional data required to clearly define pediatric upper dose limit.
  • Note: For infants <6 months, dose reductions (eg, by 30%) have been suggested by experts.
  • Head and neck blocks: 0.05 mL/kg
  • Maxillary nerve: 0.15 mL/kg.

  • Upper extremity blocks:

    • Brachial plexus: 0.2 to 0.3 mL/kg
    • Digital nerve: ≤0.2% (2 mg/mL) solution: 0.05 mL/kg

  • Trunchal blocks:

    • Transversus abdominis plane: 2 to 0.5 mL/kg
    • Ilioinguinal nerve: 0.75 mL/kg
    • Rectus sheath: 1 to 0.2 mL/kg

  • Lower extremity blocks:

    • Femoral nerve: 2% to 0.5% (2 to 5 mg/mL) solution: 0.2 to 0.4 mL/kg.
    • Sciatic nerve: 2 to 0.3 mL/kg

Ropivacaine Dose for Continuous peripheral nerve block infusion (CPNB):

• Infants ≥6 months, Children, and Adolescents:

  • Initial bolus: 0.2% (2 mg/mL) solution:

    • Dose depends on nerve catheter location:
      • Commonly reported dose range: ~0.5 to 1.32 mg/kg;
      • some patients and/or catheter/nerve sites may need a higher bolus dose;
      • a trial evaluating 403 pediatric catheter placements reported an overall median bolus for all catheter sites of 1.32 mg/kg (IQR: 0.82 to 1.95 mg/kg);
      • another trial reporting on 339 pediatric catheter placements reported a mean initial bolus dose of 0.49 to 0.98 mg/kg.

  • Continuous peripheral nerve block infusion:

    • 2% (2 mg/mL) solution:
    • Reported mean rate range:
      • 0.11 to 0.25 mg/kg/hour (most experience reported at 0.2 to 0.25 mg/kg/hour);
    • reported IQR range from 403 pediatric catheter placements:
      • 0.12 to 0.33 mg/kg/hour (depending upon catheter site) with a usual duration <72 hours;
      • majority of experience is postoperative pain management after orthopedic procedures including administration via On-Q pump or Ambu Smart-Infuser

Ropivacaine Dose in the treatment of Spinal anesthesia: Limited data available:

• Infant, Children, and Adolescents ≤17 years:

  • Intrathecal (via LP site; L 3-5):
    • Preservative-free 0.5% (5 mg/mL) isobaric solution:
      • 0.5 mg/kg;
      • maximum dose: 20 mg/dose.

Pregnancy Risk Factor B

• Animal reproduction studies have not shown any adverse events.
• Ropivacaine can cross the placenta during labor and delivery to cause an epidural block. This could lead to variable neonatal or fetal effects (eg CNS or cardiovascular depression).
• Neonatal and fetatal adverse events include neonatal bradycardia (12%) and neonatal jaundice (8%) as well as low Apgar scores (3%), fetal distress (2%) or neonatal respiratory disorders (3%).
• Systemic absorption can also cause maternal hypotension.
• Hypotension cases: Position the pregnant woman in the left lateral decubitus to avoid aortocaval compression caused by the gravid.
• The second stage of labor may be prolonged by epidural anesthesia.

Use of opivacaine while breastfeeding

• It is unknown if ropivacaine is absorbed into breast milk. However, it is likely that the infant's exposure will be very low.
• Ropivacaine should not be administered to nursing mothers, according to the manufacturer.

Ropivacaine Dose in Kidney Disease:

• There are no dosage adjustments provided in the manufacturer’s labeling.
• However, ropivacaine and its metabolites are renally excreted, and the risk of toxic reactions may be greater. 

Ropivacaine Dose in Liver disease:

• There are no dosage adjustments provided in the manufacturer’s labeling.
• Use cautiously; ropivacaine undergoes hepatic metabolism and patients may be at increased risk for developing toxic drug levels. 

Common Side Effects of Ropivacaine:

• Cardiovascular:

  • Hypotension
  • Bradycardia

• Gastrointestinal:

  • Nausea
  • Vomiting

• Neuromuscular & Skeletal:

  • Back Pain

Less Common Side Effects of Ropivacaine:

• Cardiovascular:

  • Chest Pain
  • Hypertension
  • Tachycardia

• Central Nervous System:

  • Headache
  • Pain
  • Paresthesia
  • Dizziness
  • Chills
  • Rigors
  • Hypoesthesia
  • Anxiety

• Dermatologic:

  • Pruritus

• Endocrine & Metabolic:

  • Hypokalemia

• Genitourinary:

  • Oliguria
  • Urinary Retention
  • Urinary Tract Infection
  • Disorder Of Breast Milk Secretion
  • Poor Progression Of Labor

• Hematologic & Oncologic:

  • Anemia

• Neuromuscular & Skeletal:

  • Muscle Cramps

• Respiratory:

  • Dyspnea
  • Rhinitis

• Miscellaneous:

  • Fever
  • Postoperative Complication

Contraindications to Ropivacaine:

• Hypersensitivity to ropivacaine, local anesthetics of amide type (eg bupivacaine or mepivacaine, lidocaine) or any component in the formulation

Canadian labeling: Additional contraindications not in US labeling

• Intravenous regional anesthesia (Bier Block);
• Anesthesia for obstetric paracervical blocks

Warnings and precautions

• Toxicity to the CNS:

  • After each injection of local anesthetic, it is important to monitor the patient's consciousness. Any signs such as restlessness, anxiety or dizziness, blurred sight, blurred vision, tremors and depression may indicate CNS toxicity.
  • The goal of treatment is to treat the symptoms and be supportive.

• Infusion-related intra-articular chondrolysis

  • It is not approved to continue intra-articular injection of local anesthetics following arthroscopic, or other surgical procedures.
  • Chondrolysis, which is primarily found in the shoulder joint, has been reported following infusion. Some cases may require arthroplasty or shoulder replacement.

• Methemoglobinemia

  • This has been reported using local anesthesia; clinically significant methemoglobinemia must be treated immediately.
  • The onset of symptoms can be delayed or immediate (hours) following anesthesia exposure.
  • Patients with glucose-6-phosphate hydrogenase deficiencies, congenital or irreversible methemoglobinemia, cardiac compromise, exposure to oxidizing agent or their metabolites, and infants under 6 months old are more vulnerable. They should be closely monitored for signs such as fatigue, cyanosis and rapid pulse.

• Respiratory arrest

  • Rare cases of sudden respiratory arrest have been reported to be associated with local anesthetics.

• Seizures

  • Unintentional intravascular injections may have caused cardiac arrest-like convulsions.

• Cardiovascular disease

  • Patients with hypotension, hypovolemia or heart block should be cautious. They may be more at risk of toxic effects.

• Hepatic impairment

  • Patients with hepatic impairment should be cautious; they may be at greater risk of toxic effects.

• Neurological disorders

  • Patients with neurological disorders should be cautious; they may be at greater risk of toxic effects.

• Porphyria

  • Patients with severe porphyria should be cautious; alternative options may be considered.

• Psychiatric disorders

  • Patients with psychiatric disorders should be cautious; they may be at greater risk of toxic effects.

• Renal impairment

  • Patients with severe renal impairment should be cautious; they may be at higher risk of toxicities.

Monitoring parameters:

• Heart rate
• blood pressure
• ECG monitoring (if used with antiarrhythmics)

How to administer Ropivacaine?

Administration via

• Local infiltration
• Epidural block
• Infusion epidural
• Bolus intermittent

A test dose of epinephrine, which is a short-acting local anesthetic, should be administered before ropivacaine administration. It is recommended to take a small amount of ropivacaine in increments. You should not give an excessive amount of anesthetic in a short time. On-Q is an infusion pump that can be used to administer local anesthetics such as bupivacaine (or lidocaine), ropivacaine or pre- or post-operative regional anesthesia. Chondrolysis has been reported when On-Q pumps are injected directly into the shoulder. On-Q pumps should not be placed directly in any joint.

Mechanism of action of Ropivacaine:

• It prevents both the initiation of and the conduction of nerve impulses.
• By decreasing the neuronal membrane’s permeability for sodium ions, it results in inhibitions of depolarization with consequent blockage of conduction.

The onset of action: Anesthesia (route dependent):

• 3 to 15 minutes

Duration (dose and route dependent):

• 3 to 15 hours

Metabolism:

• Hepatic, via CYP1A2 to metabolites

Half-life elimination:

• Children: Epidural: Terminal phase: 4.9 hours (range: 3 to 6.7 hours)
• Adults: Epidural: 5 to 7 hours; IV: Terminal: 111 ± 62 minutes

Time to peak serum concentration: Dose and route dependent: Caudal:

• Infants: Median: 60 minutes (range: 15 to 90 minutes).
• Children: Mean: 60 minutes (range: 12 to 249 minutes.

Excretion:

• Urine (86% as metabolites)

International Brand Names of Ropivacaine:

• Naropin
• Anaropin
• Narop
• Naropeine
• Naropin
• Naropina
• Ropibam
• Ropica
• Ropiva

Ropivacaine Brand Names in Pakistan: