AHFS Class:

• Local Anesthetics 72:00

Generic Name(s):

• Ropivacaine Hydrochloride

Ropivacaine hydrochloride is a long-acting local anesthetic of the amide type.1,3,14

Local or Regional Anesthesia and Analgesia

Ropivacaine hydrochloride is used to produce local or regional anesthesia for surgery (including cesarean section) and for the management of acute pain (e.g., postoperative pain, labor pain).1 When used for postoperative pain, ropivacaine should be administered as a component of multimodal analgesia (i.e., simultaneous use of a combination of analgesic agents and techniques that target different mechanisms).220 (See Uses in the Local Anesthetics, Parenteral, General Statement 72:00.)

Efficacy of ropivacaine for surgical anesthesia has been evaluated in numerous studies in which the drug was administered as an epidural block for general surgery or cesarean section, or as a peripheral nerve block (e.g., brachial plexus block).1,8,9,10,12,14,15 Studies in patients undergoing general surgery demonstrated that epidural administration of ropivacaine hydrochloride in doses of 100-200 mg was effective in producing T10 sensory blockade with an onset of 5-13 minutes and duration of 3-5 hours; in general, higher doses produced a more profound block with a greater duration of effect.1 Studies in patients undergoing cesarean section demonstrated that epidural administration of ropivacaine hydrochloride 0.5% was effective in producing T6 sensory blockade with an onset of 11-26 minutes and duration of 1.7-3.2 hours; adequate muscle relaxation also was achieved during surgery.1 In several active-controlled studies using epidural ropivacaine hydrochloride 0.75% for cesarean section, median onset of a T6 block was 4-15 minutes.1 When used for brachial plexus block, the anesthetic efficacy of ropivacaine hydrochloride appeared to vary based on the concentration (0.5 or 0.75%) and anesthetic technique (e.g., supraclavicular versus axillary block) used.1

Efficacy of ropivacaine hydrochloride for acute pain management has been evaluated in several studies using 0.2 or 0.25% concentrations of the drug in patients with labor pain or postoperative pain (after abdominal or orthopedic surgeries).1,13,14 When administered epidurally as a continuous infusion or intermittent injections for labor pain, ropivacaine provided adequate relief of pain and had a similar effect on neonatal outcomes as bupivacaine.1 When used to control postoperative pain after abdominal or orthopedic surgery, continuous epidural infusion of ropivacaine hydrochloride 0.2% for up to 72 hours produced adequate analgesia with only slight and nonprogressive motor blockade; in addition, a reduction in the need for rescue analgesics (e.g., morphine) was observed.1

Efficacy of ropivacaine hydrochloride for local infiltration has been evaluated in studies using the 0.5% concentration of the drug to provide surgical anesthesia or postoperative analgesia; in these studies, use of ropivacaine resulted in lower pain scores and a reduction in analgesic consumption.1

Compared with bupivacaine, ropivacaine generally has a similar onset and duration of sensory block, but a lower intensity and shorter duration of motor block.1,3,8,9,10,12,13,14,15 Ropivacaine appears to have a lower potential for CNS and cardiovascular toxicity than bupivacaine.3,8,9,10,11,12,14,15 (See Description.)

Ropivacaine should not be used for obstetrical paracervical block, retrobulbar block for ophthalmic surgery, or spinal anesthesia (subarachnoid block) because of insufficient data to support such uses.1 Ropivacaine also should not be used for IV regional anesthesia (Bier block) because of the lack of clinical experience and risk of toxicity.1

Administration

Ropivacaine hydrochloride may be administered by epidural block, peripheral nerve block (e.g., brachial plexus block), or local infiltration.1,6 The manufacturer states that ropivacaine should not be used for obstetrical paracervical block, retrobulbar block, or spinal anesthesia (subarachnoid block), and should not be administered using the Bier block technique (IV regional anesthesia).1

Local anesthetics, including ropivacaine, have been administered by continuous intra-articular infusion† (e.g., for control of postoperative pain); however, such use has been associated with chondrolysis.1,5,200,201,202,203,204,205,206,207,208,209 (See Cautions: Musculoskeletal Effects in the Local Anesthetics, Parenteral, General Statement 72:00.)

To prevent intravascular or subarachnoid injection of a large epidural dose of ropivacaine hydrochloride, a test dose (e.g., 3-5 mL of a short-acting local anesthetic solution containing epinephrine) should be injected prior to administering the total dose.1,7 When clinical conditions permit, use of a test dose solution that contains epinephrine should be considered to detect inadvertent intravascular injection.1,7 The test dose should be repeated if the epidural catheter is displaced.1 An adequate time for onset of anesthesia should be allowed following administration of each test dose.1

Dispensing and Administration Precautions

Local anesthetics should only be administered by clinicians who are experienced in the diagnosis and management of dose-related toxicities and other acute emergencies associated with these agents.1 Resuscitative equipment, oxygen, drugs, and personnel required for the treatment of adverse reactions should be immediately available whenever ropivacaine is administered.1 For specific procedures and techniques of administration, specialized references should be consulted.1

Ropivacaine should be administered slowly in incremental doses to reduce the risk of adverse effects (e.g., local anesthetic systemic toxicity).1,7 Inadvertent administration of large volumes of local anesthetic into highly vascularized areas can result in high plasma concentrations and increase the potential for systemic toxicity.1,8 Frequent aspirations for blood or cerebrospinal fluid (when applicable) should be performed to avoid intravascular administration or inadvertent subarachnoid injection; however, a negative aspiration does not ensure protection against inadvertent intravascular or subarachnoid injection.1,7

Patients should have a functioning IV line prior to receiving a major regional nerve block.1

Injections into the head and neck area require particular care since serious adverse effects have been reported due to complications from the anesthetic technique.1

Standardize 4 Safety

Standardized concentrations for ropivacaine have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. 251Multidisciplinary expert panels were convened to determine recommended standard concentrations. 251Because recommendations from the S4S panels may differ from the manufacturer's prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label. 251 For additional information on S4S (including updates that may be available), see [Web].251

Dosage

Dosage of ropivacaine hydrochloride is expressed in terms of ropivacaine hydrochloride.1 Dosage of ropivacaine hydrochloride varies with the anesthetic procedure, degree of anesthesia required, surgical site, and individual patient response.1 The smallest dose and lowest concentration required to produce the desired effect should be used.1,7 Rapid administration of a large single dose should be avoided.1,7 The manufacturer's dosage recommendations are based on the expected average dosage range necessary to produce a successful block in adults and should be used as a general guideline.1

Surgical Anesthesia

For lumbar epidural anesthesia in general surgery, the recommended adult dose of ropivacaine hydrochloride is 15-30 mL of a 0.5% solution (75-150 mg), 15-25 mL of a 0.75% solution (113-188 mg), or 15-20 mL of a 1% solution (150-200 mg); onset of anesthesia is approximately 10-30 minutes and duration is approximately 2-6 hours depending on the dose administered.1 For thoracic epidural anesthesia in general surgery, the recommended adult dose of ropivacaine hydrochloride is 5-15 mL of a 0.5 or 0.75% solution (25-113 mg); onset of anesthesia is about 10-20 minutes depending on the dose administered.1

For lumbar epidural anesthesia in cesarean section, the recommended adult dose of ropivacaine hydrochloride is 20-30 mL of a 0.5% solution (100-150 mg) or 15-20 mL of a 0.75% solution (113-150 mg); onset of anesthesia is approximately 10-25 minutes and duration is approximately 2-5 hours depending on the dose administered.1

For major nerve blocks (e.g., brachial plexus block), the recommended adult dose of ropivacaine hydrochloride is 35-50 mL of a 0.5% solution (175-250 mg) or 10-40 mL of a 0.75% solution (75-300 mg); onset of anesthesia is approximately 10-30 minutes and duration is approximately 5-10 hours depending on the dose administered.1 Doses given for major nerve blocks must be adjusted based on the site of administration and patient status.1 A ropivacaine hydrochloride dose of 300 mg for brachial plexus block may result in plasma concentrations that approach the threshold for CNS toxicity and should be administered with caution.1,4 Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions regardless of the local anesthetic used.1

For production of a field block (e.g., minor nerve blocks and infiltration), the recommended adult dose of ropivacaine hydrochloride is 1-40 mL of a 0.5% solution (5-200 mg); onset of anesthesia is approximately 1-15 minutes and duration is approximately 2-6 hours depending on the dose administered.1

Acute Pain Management

For the management of labor pain, an initial lumbar epidural injection of 20-40 mg (10-20 mL of a 0.2% solution) is recommended in adults, followed by a continuous epidural infusion of 12-28 mg/hour (6-14 mL/hour of a 0.2% solution) or incremental epidural injections (top-ups) of 20-30 mg/hour (10-15 mL/hour of a 0.2% solution).1 Following administration of the initial dose, onset of anesthesia is approximately 10-15 minutes and duration is approximately 0.5-1.5 hours.1

For the management of postoperative pain in adults, a continuous lumbar or thoracic epidural infusion of ropivacaine hydrochloride at a rate of 12-28 mg/hour (6-14 mL/hour of a 0.2% solution) is recommended.1 In clinical studies, epidural infusions of the drug were administered for up to 72 hours.1 For local infiltration analgesia (e.g., minor nerve block) in the management of postoperative pain, the recommended adult dose of ropivacaine hydrochloride is 1-100 mL of a 0.2% solution (2-200 mg) or 1-40 mL of a 0.5% solution (5-200 mg).1 Onset of analgesia is approximately 1-5 minutes and duration is approximately 2-6 hours depending on the dose administered.1

Special Populations

The possibility of increased toxicity should be considered in patients with severe hepatic or renal impairment, and dosage of ropivacaine hydrochloride should be adjusted accordingly.1

The usual dosages of ropivacaine hydrochloride generally should be reduced in geriatric, debilitated, or acutely ill patients.1 Caution should be exercised when the drug is administered for prolonged periods (e.g., greater than 70 hours) in debilitated patients because of the risk of reaching a toxic plasma concentration or inducing local neural injury.1 (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Contraindications

Known hypersensitivity to ropivacaine hydrochloride or other local anesthetics of the amide type.1

Warnings/Precautions

Warnings

Ropivacaine hydrochloride shares the toxic potentials of the local anesthetics, and the usual precautions of local anesthetic therapy should be observed. (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.)

Administration Precautions

Because of the potential for serious adverse effects, special precautions should be taken during administration of ropivacaine.1,7 (See Dosage and Administration: Administration.) Oxygen, resuscitative equipment, drugs, and personnel required for the treatment of adverse reactions should be immediately available.1 A delay in the proper management of dose-related toxicities may result in acidosis, cardiac arrest, and possibly death.1

Risk of Chondrolysis Associated with Intra-articular Infusions of Local Anesthetics

Chondrolysis (necrosis and destruction of articular cartilage) has been reported in patients receiving continuous intra-articular infusions of local anesthetics for treatment of postoperative pain.1,200,202,203,204,205,206,207,208,209 In most reported cases, chondrolysis occurred in the shoulder joint following arthroscopic or other shoulder surgery.1 (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.)

Accidental Injection

Accidental intravascular or subarachnoid injection of ropivacaine may cause cardiac and CNS toxicity.1 Cardiac arrests have been reported rarely following unintentional accidental intravascular administration of the drug and were observed mostly in geriatric patients and in those with concomitant heart disease.1 (See Cardiovascular Effects and also see CNS Effects under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) Clinical pharmacology studies and animal studies suggest that the cardiotoxic potential of ropivacaine is less than that of bupivacaine, although both drugs are substantially more toxic than lidocaine.1 Serious adverse effects were not observed in clinical studies that were performed to evaluate the safety of ropivacaine injected into the subarachnoid space.1

Aspiration should be performed prior to administration of ropivacaine to avoid intravascular or subarachnoid injection; however, a negative aspiration does not ensure against an intravascular or subarachnoid injection.1

Sensitivity Reactions

Although rare, allergic-type reactions have been reported with ropivacaine and may include manifestations such as urticaria, pruritus, erythema, angioedema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly anaphylactoid symptoms (including severe hypotension).1

Cross-hypersensitivity between ropivacaine and other amide-type local anesthetics has been reported.1 (See Cautions: Contraindications.)

Other Warnings and Precautions

CNS Effects

Ropivacaine can cause adverse CNS effects if absorbed systemically.1,3,4,7 (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.) Restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of CNS toxicity.1,7 Prolonged blocks can increase the risk of toxic plasma concentrations or induce local neural injury.1 Administration of 300 mg of ropivacaine hydrochloride for brachial plexus block may increase the risk of CNS toxicity.1,4

Patients should be carefully monitored for possible CNS toxicity after administration of ropivacaine.1

Cardiovascular Effects

Ropivacaine can cause adverse cardiovascular effects (e.g., decreased cardiac output, arrhythmias, reduced myocardial contractility and conductivity) if absorbed systemically.1,7,14 (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.)

Patients should be carefully monitored for possible cardiovascular toxicity and vital signs should be obtained after administration of the local anesthetic.1 If cardiac arrest occurs, prolonged resuscitative efforts may be required.1 Ropivacaine should be used with caution in patients with impaired cardiovascular function, hypotension, hypovolemia, or heart block.1

Familial Malignant Hyperthermia

Many drugs used during the conduct of anesthesia may trigger familial malignant hyperthermia, but it is not known whether amide-type local anesthetics such as ropivacaine can trigger this reaction.1 Therefore, a standard protocol for familial malignant hyperthermia management should be available.1

Specific Populations

Pregnancy

Category B.1

There are no adequate and well-controlled studies of ropivacaine in pregnant women.1 Animal reproductive studies have not shown any evidence of teratogenicity or adverse developmental effects; however, maternal toxicity has been observed.1 Local anesthetics rapidly cross the placenta during epidural administration and can cause varying degrees of maternal, fetal, and neonatal toxicity.1 Ropivacaine should be used during pregnancy only if the benefits outweigh the risks.1

Maternal hypotension has occurred with the use of ropivacaine for obstetrical pain relief.1,13 (See Cautions in the Local Anesthetics, Parenteral, General Statement 72:00.)

Lactation

Ropivacaine is distributed into milk in rats; it is not known whether the drug or its metabolites are distributed into human milk.1 Based on the milk to plasma concentration ratio and estimated exposures in rats, infant exposure to ropivacaine from breastfeeding is expected to be far less than the exposure in utero.1 Ropivacaine should be used with caution in nursing women.1

Pediatric Use

The manufacturer states that efficacy and safety of ropivacaine have not been established in pediatric patients;1 however, the drug has been used in children for postoperative analgesia.14,15

Geriatric Use

In clinical studies of ropivacaine, 27% of patients receiving the drug were 65 years of age or older and 4% were 75 years of age or older.1 The drug was found to be safe and effective in these patients.1

Differences in various pharmacodynamic measures of ropivacaine have been observed with increasing age.1 In one clinical study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure declined with age for the first hour following epidural administration, and the intensity of motor blockade increased with age.1

Because ropivacaine and its metabolites are substantially excreted by the kidneys, the risk of toxic reactions to the drug may be greater in patients with renal impairment.1 Dosage should therefore be selected with caution in geriatric patients, usually starting at the lower end of the dosage range, since such patients are more likely to have decreased hepatic, renal, and/or cardiac function as well as concomitant illnesses.1 The manufacturer states that it may be useful to monitor renal function in geriatric patients.1

Hepatic Impairment

Ropivacaine is extensively metabolized in the liver and should be used with caution in patients with hepatic impairment, particularly in those receiving repeat doses of the drug.1 Patients with severe hepatic impairment are at greater risk of developing toxic plasma concentrations.1

Renal Impairment

Ropivacaine and its metabolites are eliminated by the kidneys; therefore, patients with renal impairment may be at increased risk of drug-related toxicity.1

Common Adverse Effects

Adverse effects reported in 5% or more of patients receiving ropivacaine hydrochloride in clinical studies include hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.1

No formal drug interaction studies have been performed to date with ropivacaine hydrochloride.1

Drugs Affecting or Affected by Hepatic Microsomal Enzymes

Ropivacaine is metabolized to its major metabolite (3-hydroxyropivacaine) by cytochrome P-450 (CYP) isoenzyme 1A2.1 Potent inhibitors of CYP1A2, such as fluvoxamine, can increase plasma ropivacaine concentrations when administered concomitantly.1 When ropivacaine was coadministered with fluvoxamine (25 mg twice daily for 2 days), plasma clearance of ropivacaine was reduced by 70%.1 Caution should be exercised when ropivacaine is administered concomitantly with CYP1A2 inhibitors.1 There also is a possibility that drugs known to be metabolized by CYP1A2 (e.g., theophylline, imipramine) can interact with ropivacaine via competitive inhibition.1

When ropivacaine was administered 1 hour after ketoconazole (100 mg twice daily for 2 days), a selective and potent inhibitor of CYP3A4, a 15% reduction in plasma clearance of ropivacaine was observed; however, the effect was not clinically important.1,14 When ropivacaine was coadministered with rifampin, an inducer of CYP3A4, plasma clearance of ropivacaine was increased by 93%.14

Antiarrhythmic Agents

Concomitant use of class III antiarrhythmic agents (e.g., amiodarone) with ropivacaine has not been studied, but may result in additive cardiac effects; the manufacturer recommends close surveillance and to consider ECG monitoring.1

Local Anesthetics

Caution is advised when ropivacaine is used with other local anesthetics or drugs that are structurally related to amide-type local anesthetics because the toxic effects of these drugs are additive.1

Description

Ropivacaine hydrochloride is a long-acting local anesthetic of the amino amide class.1,3 Local anesthetics block the generation and conduction of nerve impulses possibly by increasing the threshold for electrical excitation, slowing the propagation of the nerve impulse, and reducing the rate of rise of the action potential.1 Progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers.1 Unlike most other local anesthetics, the addition of epinephrine has no substantial effect on the onset time or duration of ropivacaine.1,3 The onset, depth, and duration of sensory block with ropivacaine are generally similar to bupivacaine; however, the depth and duration of motor block are less than bupivacaine.1

Ropivacaine is structurally related to bupivacaine; however, unlike bupivacaine, which exists in its racemic form, ropivacaine is an S -enantiomer.1,14 Ropivacaine is less lipophilic and less likely to penetrate large myelinated nerve fibers than bupivacaine.14 These physiochemical and stereoselective differences are thought to contribute to the lower cardiac and CNS toxicity of ropivacaine compared with bupivacaine.11,14,15

Advice to Patients

Importance of advising patients of the possibility of temporary loss of sensation and motor activity following lumbar epidural anesthesia.1

Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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