SUMMARY
Sensorcaine® (bupivacaine HCl) injections are sterile isotonic solutions that contain a local anesthetic agent with and without epinephrine (as bitartrate) 1:200,000 and are administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. Solutions of bupivacaine HCl may be autoclaved if they do not contain epinephrine.
Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for 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 non-obstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS.)
The routes of administration and indicated Sensorcaine concentrations are:
local infiltration 0.25%
peripheral nerve block 0.25%, 0.5%
retrobulbar block 0.75%
sympathetic block 0.25%
lumbar epidural 0.25%, 0.5% and 0.75%
(non-obstetrical)
caudal 0.25%, 0.5%
epidural test dose (see PRECAUTIONS)
(See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.
Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservative and, therefore, should not be used for these procedures.
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NEWS HIGHLIGHTSMedia Articles Related to Sensorcaine MPF (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...
Published Studies Related to Sensorcaine MPF (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
Clinical Trials Related to Sensorcaine MPF (Bupivacaine)
2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula [Recruiting]
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.
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.
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.
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.
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