Marcaine (Bupivacaine Hydrochloride) - Summary

MARCAINE SUMMARY

MARCAINE is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Solutions of MARCAINE may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless.

Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino, or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.

MARCAINE — Sterile isotonic solutions containing sodium chloride. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 4 and 6.5 with sodium hydroxide or hydrochloric acid.

MARCAINE with epinephrine 1:200,000 (as bitartrate)—Sterile isotonic solutions containing sodium chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg epinephrine bitartrate, with 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as stabilizer. In multiple-dose vials, each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to between 3.4 and 4.5 with sodium hydroxide or hydrochloric acid. The specific gravity of MARCAINE 0.5% with epinephrine 1:200,000 (as bitartrate) at 25°C is 1.008 and at 37°C is 1.008.

MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)

Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.

MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS.

The routes of administration and indicated MARCAINE concentrations are:

• local infiltration	0.25%
• peripheral nerve block	0.25% and 0.5%
• retrobulbar block	0.75%
• sympathetic block	0.25%
• lumbar epidural	0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia)
• caudal	0.25% and 0.5%
• epidural test dose	0.5% with epinephrine 1:200,000
• dental blocks	0.5% with epinephrine 1:200,000

(See DOSAGE AND ADMINISTRATION for additional information.)

Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.

See all Marcaine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Marcaine (Bupivacaine)

New Data Support The Benefits Of EXPAREL For Postsurgical Analgesia Following Aesthetic Plastic Surgery Procedures
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2013.04.16]
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) have announced results from EXCLAIM, its Phase 4 prospective, observational study to assess the use of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical analgesia in patients undergoing four common plastic surgery procedures...

Patients With Sleep Apnea Undergoing Joint Replacement Have Improved Outcomes With Regional Anesthesia
Source: Arthritis / Rheumatology News From Medical News Today [2013.05.07]
Using regional anesthesia instead of general anesthesia in patients with sleep apnea undergoing total joint replacement decreases major complications by 17%, according to a study published online, ahead of print, in the journal Regional Anesthesia and Pain Medicine...

Lower Rates Of Complications In Hip And Knee Replacement Using Regional Anesthesia Technique
Source: Arthritis / Rheumatology News From Medical News Today [2013.05.03]
A highly underutilized anesthesia technique called neuraxial anesthesia, also known as spinal or epidural anesthesia, improves outcomes in patients undergoing hip or knee replacement, according to a new study by researchers at Hospital for Special Surgery...

General Anesthesia Not Linked to Raised Risk for Dementia
Source: MedicineNet Dementia Specialty [2013.05.02]
Title: General Anesthesia Not Linked to Raised Risk for Dementia
Category: Health News
Created: 5/1/2013 12:35:00 PM
Last Editorial Review: 5/2/2013 12:00:00 AM

Success Rates Of Turning Breech Babies Increased By Anesthesia, Delivery Costs Reduced
Source: Pain / Anesthetics News From Medical News Today [2013.04.22]
When a baby is in the breech position at the end of pregnancy, obstetricians can sometimes turn the baby head-down to enable a safer vaginal birth. In the past, women were not given anesthesia during the turning procedure, which requires the physician to push on the woman's abdomen while monitoring the baby with ultrasound...

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Published Studies Related to Marcaine (Bupivacaine)

Periarticular infiltration of 0.25% bupivacaine on top of femoral nerve block and intrathecal morphine improves quality of pain control after total knee arthroplasty: a randomized double-blind placebo controlled clinical trial. [2012]
CONCLUSION: Adding periarticular infiltration to femoral block and intrathecal

Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. [2012]
novel formulation of bupivacaine... CONCLUSIONS: A focused assessment of ECG data from a phase 2 study and cardiac

Analgesic control and functional outcome after knee arthroscopy: results of a randomized double-blinded trial comparing a hyaluronic acid supplement with bupivacaine. [2012]
functional outcomes after knee arthroscopy... CONCLUSIONS: There was no benefit of HA injection immediately at the end of knee

A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. [2012]
examination with respect to the integrity of the breast implants... CONCLUSIONS: At a two-year follow-up assessment, DepoFoam bupivacaine was not

The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. [2012]
augmentation mammaplasty under general anesthesia... CONCLUSIONS: DepoFoam bupivacaine trended toward benefit versus bupivacaine HCl

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Clinical Trials Related to Marcaine (Bupivacaine)

2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula [Recruiting]

Comparison of Standard and Minidose Spinal Anesthesia for Cesarean Section Operation Using Marcaine Spinal 0.5% Heavy [Not yet recruiting]
The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effects with this combination than with convenient dose of Bupivacaine.

Bupivacaine Effectiveness and Safety in SABER™ Trial [Recruiting]
This is a research study testing SABERâ„¢-Bupivacaine (an experimental pain-relieving medication). SABERâ„¢-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (side effects) associated with the use of SABERâ„¢-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal surgeries.

Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain [Not yet recruiting]
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (bupivacaine) or placebo (saline) delivered via pain pump to the mastectomy site. Candidates will have chosen to have a mastectomy on one side immediately followed with tissue expander placement breast reconstruction.

Patients will be randomized 1: 1 to bupivacaine- (treatment) or saline-(placebo) filled percutaneously-placed pain pumps; neither the participants nor the study staff will know participants' treatment. Data on patient-perceived pain and pain medication use will be collected before surgery, during surgery, and after surgery on Days 1, 2, 3, 7, and 90, and at Years 2 and 4 by phone.

The investigators hypothesize that patients randomized to the treatment (bupivacaine) group will have significantly lower pain scores and use less pain medicine than patients who receive placebo during the first 90 days following their surgery. The Year 2 and Year 4 follow-ups are included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to complete the same questionnaires as at the Day 90 follow up.

Epidural Fentanyl-bupivacaine Versus Clonidine-bupivacaine for Breakthrough Pain in Advanced Labor [Not yet recruiting]
Epidural analgesia is widely regarding as the most effective analgesic strategy for labor pain. Modern practice is to utilize dilute local anesthetics as a continuous infusion along with an opioid, e. g., our common "recipe" of 12 ml/hr of 0. 0625% bupivacaine with 2 micrograms/ml fentanyl, after the initial dose to maintain patient comfort until delivery. This dose of the infusion often provides adequate comfort without interfering with the mobility of the patient and her ability to effectively push during delivery. However, this low dose epidural infusion strategy often results in recurrence of pain after an initial pain free period.

This breakthrough pain is treated by administering small boluses of analgesics via the epidural catheter. The pain occurring in labor is initially of visceral origin and is mediated by pain fibers originating from the low thoracic and upper lumbar segments of the spinal cord. As labor progresses to the late first phase (also known as transitional stage), pain sensations originating from the distension of the pelvic floor, vagina and perineum adds a somatic component to labor pain. This type of breakthrough pain is often difficult to treat.

Although requests from patients to alleviate late stage breakthrough pain are common, no one knows the most effective strategy for pain management in this stage of labor. This study is designed to compare the efficacy of two treatments for controlling late first stage breakthrough pain during labor with an epidural infusion in place: clonidine-bupivacaine versus fentanyl-bupivacaine.

Women who have labor epidural analgesia in place will be enrolled to be randomized if and when they present with breakthrough pain in the late first stage or second stage of labor (≥ 8 cm dilated). They will receive 8 ml of a solution containing 10 mg bupivacaine and 75 micrograms of either fentanyl (an opioid or "narcotic") or clonidine (an "alpha-2 agonist known to be effective as an epidural analgesic).

Pain relief, labor progress and outcome will be assessed to compare fentanyl versus clonidine.

It is the hypothesis of this study that clonidine added to bupivacaine is a better analgesic than fentanyl added to bupivacaine for breakthrough pain in advanced labor.

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Reports of Suspected Marcaine (Bupivacaine) Side Effects

Cardiac Arrest (8),  Anaesthetic Complication (6),  Respiratory Distress (5),  Brain Oedema (4),  Hypoxic-Ischaemic Encephalopathy (4),  Drug Ineffective (3),  Anaphylactic Reaction (3),  Pain (3),  Anaphylactic Shock (3),  Oedema Peripheral (3), more >>