Ropivacaine

Mechanism-of-action class: Sodium Channel Interactions.

• Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration.

• Ropivacaine Hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type.contraindicated

• See Table 1 for Dosage Recommendations. ( 2.2 ) 2.1 Important Administration Instructions There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Ropivacaine Hydrochloride Injection is not approved for this use [see Warnings and Precautions ( 5.3 )]. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly. Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block.

• Delay in proper management of dose-related toxicity, under ventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. ( 5.1 ) • In performing Ropivacaine Hydrochloride blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. ( 5.2 ) • Intra-articular infusions of local anesthetics may cause chondrolysis. Ropivacaine Hydrochloride is not approved for this use. ( 5.3 ). • Signs of methemoglobinemia may occur. ( 5.4 ) 5.1 General Warnings and Precautions Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an IV line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Adverse Reactions ( 6) and Overdosage ( 10.1 )]. Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.

Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Ropivacaine Hydrochloride at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event. Because clinical trials are conducted under widely conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Incidence ≥ 5% For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥ 5% in all clinical studies (N=3988): hypotension (37%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5%).

8.1 Pregnancy Risk Summary There are no available human data on use of Ropivacaine Injection in pregnant women to evaluate a drug- associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations). No teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the MRHD of 250 mg for nerve block use, based on body surface area (BSA) comparisons and a 60 kg human weight (see Animal data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12 )].

Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution [see Adverse Reactions ( 6 ) and Warnings and Precautions ( 5.1 , 5.2 , 5.6 )]. 10.1 Treatment Therapy with Ropivacaine Hydrochloride should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Ropivacaine Hydrochloride; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Ropivacaine Hydrochloride, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered.

• Sep 24, 1996NDANDA020533Fresenius Kabi Usa
• Jul 13, 2016ANDAANDA205612Eugia Pharma
• Jun 11, 2018ANDAANDA206166Inforlife
• Jun 15, 2018ANDAANDA207636Somerset Theraps Llc
• Apr 9, 2020ANDAANDA212808Caplin
• Jul 20, 2020ANDAANDA214074Hikma
• Aug 18, 2022ANDAANDA210102Gland
• Mar 8, 2023ANDAANDA216605Amneal

1. 1Dyspnoea53623%
2. 2Vomiting53523%
3. 3Drug Hypersensitivity52223%
4. 4Pneumonia51823%
5. 5Oedema51322%
6. 6Asthma49722%
7. 7Wheezing48821%
8. 8Pain23110%
9. 9Malaise2069.0%
10. 10Respiratory Tract Infection1878.2%
11. 11Chest Pain1727.5%
12. 12Drug Ineffective1727.5%
13. 13Cough1617.0%
14. 14Nasal Oedema1145.0%
15. 15Hypotension1124.9%

Recent PubMed references pinned to Ropivacaine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Determining the Optimal Volume of Ropivacaine Combined with Dexmedetomidine for Programmed Intermittent Epidural Bolus in Labor Analgesia: A Randomized Dose-Response Study.
  Drug design, development and therapy · 2026 · Song C, Ni J, Liu C, et al.
  PMID 42232097DOI 10.2147/DDDT.S598405
• Comparison between two different concentrations of ropivacaine in pericapsular nerve group block for patients undergoing total hip arthroplasty: A randomized clinical trial.
  PloS one · 2026 · Sun C, Sun Z, Liu D, et al.
  PMID 42166434DOI 10.1371/journal.pone.0348565
• Anterior Quadratus Lumborum Block with Liposomal Bupivacaine versus Ropivacaine for Postoperative Recovery in Laparoscopic Colorectal Surgery: A Randomized Controlled Trial.
  Drug design, development and therapy · 2026 · Liu D, Luo C, Zhang Y, et al.
  PMID 42152816DOI 10.2147/DDDT.S611347
• EC(50) and EC(95) of Epidural Ropivacaine for Intraoperative Analgesia During High-Intensity Focused Ultrasound for Adenomyosis: A Prospective Double-Blind Up-and-Down Concentration-Finding Study.
  Drug design, development and therapy · 2026 · Yang S, Zhang Y, Yang F, et al.
  PMID 42152815DOI 10.2147/DDDT.S594039
• Exploring the mechanism of ropivacaine in alleviating neuropathic pain via the mTOR-PKM2/STAT3-H4K12 lactylation axis.
  International immunopharmacology · 2026 · Chen M, Sun Y, Feng S, et al.
  PMID 42134294DOI 10.1016/j.intimp.2026.116838
• Effect of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures: A Randomized Controlled Noninferiority Trial.
  Acta anaesthesiologica Scandinavica · 2026 · Steensbæk MT, Yousef S, Bahuet AR, et al.
  PMID 42104772DOI 10.1111/aas.70246
• Minimum Effective Volume of 0.25% Ropivacaine for Ultrasound-Guided Superior Trunk Block with Dexmedetomidine Sedation in Shoulder Arthroscopy: A Biased Coin Up-and-Down Trial.
  Drug design, development and therapy · 2026 · Wang K, Zhang S, Lv Z, et al.
  PMID 42094212DOI 10.2147/DDDT.S597074
• Intraoperative Paragastric Vagal Nerve Block With Ropivacaine Reduces Postoperative Nausea and Pain on the Day of Surgery After Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study With Propensity Score Matching.
  Asian journal of endoscopic surgery · 2026 · Inamine S, Uesato Y
  PMID 42083085DOI 10.1111/ases.70306

The 10 most recently updated of 2,031 ClinicalTrials.gov registrations naming Ropivacaine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
  Completed · Interventional · 27 enrolled · CMC Ambroise Paré
  NCT03504462updated 2026-06-12
• PENG Block + LIA For Endoprosthesis Surgery
  Recruiting · Interventional · 100 enrolled · ASST Gaetano Pini-CTO
  NCT07239817updated 2026-06-12
• Zynrelef Versus Adductor Canal Block
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · University of Miami
  NCT07216586updated 2026-06-12
• Pectoral Nerve Block for Analgesia After Breast Augmentation
  Completed · Phase 3 · Interventional · 74 enrolled · University Hospital, Montpellier
  NCT02682186updated 2026-06-12
• Chronic Pain and Functional Prognosis After Total Knee Replacement: Continuous Locoregional Analgesia by Catheter to the Femoral Triangle Versus Tissue Infiltration as Part of an Improved Rehabilitation After Surgery Approach
  Completed · Interventional · 287 enrolled · Centre Hospitalier Departemental Vendee
  NCT03998813updated 2026-06-12
• Interscalene Block and Dysfunction Diaphragmatic
  Completed · Phase 3 · Interventional · 60 enrolled · University Hospital, Lille
  NCT04173364updated 2026-06-11
• Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty
  Completed · Interventional · 60 enrolled · Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  NCT05962970updated 2026-06-11
• Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection
  Recruiting · Interventional · 60 enrolled · Nguyen Toan Thang
  NCT07642336updated 2026-06-11
• Anesthetic Block of the Erector Muscles of the Lumbar Spine to Relieve Acute Lumbar Pain: Pilot Study
  Recruiting · Phase 3 · Interventional · 40 enrolled · Elsan
  NCT06511765updated 2026-06-10
• Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Laparoscopic Surgery
  Not yet recruiting · Interventional · 150 enrolled · Beijing Tiantan Hospital
  NCT07591233updated 2026-06-10

Frequently asked questions

How does Ropivacaine work?

Mechanism-of-action class: Sodium Channel Interactions.

What is Ropivacaine used for?

According to FDA labeling, Ropivacaine carries indications including: Ropivacaine Hydrochloride Injection is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ropivacaine?

Ropivacaine is classified as Amides, Amide Local Anesthetic, Sodium Channel Interactions, Decreased Organized Electrical Activity, Local Anesthesia.

What are the brand names for Ropivacaine?

Ropivacaine is marketed under brand names including Naropin.

What are the contraindications for Ropivacaine?

Ropivacaine labeling lists contraindications including: Ropivacaine Hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type.. Always consult the full prescribing information and a clinician.