Sensorcaine MPF (Bupivacaine Hydrochloride) - Summary

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 HIGHLIGHTS

Media Articles Related to Sensorcaine MPF (Bupivacaine)

Abdominal Surgery Without General Anesthesia
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.11.04]
A recent review in Faculty of 1000 Medicine Reports, a publication in which clinicians highlight advances in medical practice, suggests regional pain relief could be used during abdominal surgery. In this review, Michael Schaefer recommends a new approach that can be performed without the need for general anaesthetics.

Anesthesia, Exertional Heat Deaths May Be Linked
Source: MedicineNet Hyperthermia Specialty [2009.10.26]
Title: Anesthesia, Exertional Heat Deaths May Be Linked
Category: Health News
Created: 10/23/2009 4:10:00 PM
Last Editorial Review: 10/26/2009

Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Source: MedicineNet Hernia Specialty [2009.03.25]
Title: Anesthesia in Youngest Kids May be Linked to Learning Disabilities
Category: Health News
Created: 3/25/2009 2:00:00 AM
Last Editorial Review: 3/25/2009

Need For Emergency Airway Surgery For Hard-to-Intubate Patients Reduced
Source: Respiratory / Asthma News From Medical News Today [2009.11.18]
Be prepared, that old Boy Scout motto, is being applied with great success to operating room patients whose anatomy may make it difficult for physicians to help them breathe during surgery, Johns Hopkins researchers report in a new study. When patients undergo general anesthesia, they stop breathing on their own and anesthesiologists must quickly insert a tube into the airway as a first step in machine-assisted breathing.

New Technique For Injectable Facial Fillers Improves Comfort, Recovery
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.29]
Less pain during injections for wrinkle-fighting facial fillers. Less swelling afterward. Less time in the office waiting for anesthesia to take effect. These and other benefits of a new injection technique that UT Southwestern Medical Center plastic surgeons are helping pioneer are outlined in the October issue of Plastic and Reconstructive Surgery.

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Published Studies Related to Sensorcaine MPF (Bupivacaine)

Efficacy of a low-dose spinal morphine with bupivacaine for postoperative analgesia in children undergoing hypospadias repair. [2009.11]
BACKGROUND: Children undergoing hypospadias repair need to be protected from highly unpleasant sensory and emotional experiences during and after surgery. We designed a double-blinded, randomized, and placebo-controlled study to compare the efficacy of a low-dose (2 microg x kg(-1)) of intrathecal morphine with placebo for postoperative pain control of children undergoing repair of hypospadias surgery with spinal anesthesia... CONCLUSION: Spinal anesthesia provided by hyperbaric bupivacaine is adequate for distal hypospadias repair in children, but adding 2 microg x kg(-1) intrathecal morphine provides better postoperative pain control when compared to placebo in these children.

The median effective dose of bupivacaine, levobupivacaine, and ropivacaine after intrathecal injection in lower limb surgery. [2009.10]
BACKGROUND: Intrathecal anesthesia is commonly used for lower limb surgery. Bupivacaine, levobupivacaine, and ropivacaine have all been used as intrathecal drugs, but their relative potency in this context has not been fully determined. In this study, we determined the median effective dose (ED(50)) of these three local anesthetics for intrathecal anesthesia in lower limb surgery and hence their relative potencies... CONCLUSION: This study suggests that in intrathecal anesthesia for lower limb surgery, ropivacaine is less potent than levobupivacaine and bupivacaine, whereas the potency is similar between levobupivacaine and bupivacaine.

Repeated intraperitoneal instillation of levobupivacaine for the management of pain after laparoscopic cholecystectomy. [2009.09]
BACKGROUND: Laparoscopic cholecystectomy is the treatment of choice for symptomatic cholelithiasis. Postoperative pain, however, can prolong hospital stay and lead to increased morbidity. In the context of a multimodal approach to analgesia, intraperitoneal local anesthetic administration optimizes analgesia and facilitates early postoperative recovery, and it may be associated with a decreased risk of side effects... CONCLUSION: Our study showed that 2 separate doses of intraperitoneally administered levobupivacaine significantly decreased postoperative pain and the need for opioids compared with placebo. This technique is simple, safe, and without adverse effects.

A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. [2009.09]
BACKGROUND: Optimal management of pain after thoracotomy can be challenging. Continuous infusion of local anesthetic into the incision may help reduce the amount of narcotics required to control postoperative pain. To address this issue, we performed a randomized, double-blinded, controlled trial of infusion of bupivacaine versus placebo through intercostal and subcutaneous catheters after thoracotomy... CONCLUSIONS: This randomized, double-blinded, controlled trial demonstrated that the infusion of local anesthetic into the subcutaneous area and around the rib fracture site in addition to epidural analgesia did not reduce the amount of narcotic usage after a thoracotomy, nor did it affect visual analog pain scores. Pain control with intercostal catheters infusing local anesthetics did not produce a measurable pain relief beyond that provided by epidural analgesia.

The effects of intrathecal levobupivacaine and bupivacaine in the elderly. [2009.09]
The objective of this study was to compare the block durations and haemodynamic effects associated with intrathecal levobupivacaine or bupivacaine in elderly patients undergoing transurethral prostate surgery. Eighty patients were prospectively randomised to receive plain 1.5 ml levobupivacaine 0.5% (group levobupivacaine) or 1.5 ml plain bupivacaine 0.5% (group bupivacaine) in combination with fentanyl 0.3 ml (15 microg) for spinal anaesthesia...

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Clinical Trials Related to Sensorcaine MPF (Bupivacaine)

Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA [Not yet recruiting]
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0. 2 or 0. 3 mg morphine together with 0. 25 or 0. 5 % bupivacaine for single femoral nerve block

2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula [Not yet recruiting]

Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl [Recruiting]
The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.

Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time [Recruiting]
This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia.

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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