Local Anesthesia for Pain Management in Facial Fractures (LAFF Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Washington University School of Medicine
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.
How does the drug bupivacaine differ from other treatments for pain management in facial fractures?
Bupivacaine is unique because it is a long-acting local anesthetic that provides extended pain relief compared to other local anesthetics. It is administered directly to the affected area, which can reduce the need for oral narcotics and their associated side effects.
23478What data supports the effectiveness of the drug Bupivacaine, Marcaine, Sensorcaine for pain management in facial fractures?
Research shows that Bupivacaine (also known as Marcaine or Sensorcaine) is effective in managing pain due to its long-lasting effects and minimal side effects, as seen in oral surgery and breast reduction procedures. It provides good pain relief and reduces the need for additional pain medication.
12567Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Bupivacaine (Marcaine, Sensorcaine) safe for use in humans?
Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe for use in humans when used in recommended doses. It has been used effectively for pain relief in various medical procedures, with minimal side effects reported when proper dosing guidelines are followed.
12467Eligibility Criteria
This trial is for patients with facial fractures requiring surgery. Participants must be eligible for the surgical procedure and able to receive injections prior to anesthesia emergence. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
I am having surgery for a broken jaw or facial bones.
Exclusion Criteria
I was hospitalized for multiple bone fractures not including the face.
I am younger than 18 years old.
Participant Groups
The study tests if bupivacaine nerve blocks help with pain management after surgery compared to saline (a placebo). Patients are randomly assigned to get either the real drug or a placebo without knowing which one they received.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivacaine injectionExperimental Treatment1 Intervention
The surgeon will be provided with a 10 mL syringe, and he/she will be blinded to the contents of the syringe. The appropriate landmarks will be identified, and a 21, 25, or 27- gauge needle will be used to perform the nerve block with 0.25% bupivacaine.
Group II: Saline injectionPlacebo Group1 Intervention
The placebo sham injection will be performed in an identical fashion as the nerve block with the exception of using 10 mL of 0.9% saline injection instead of bupivacaine.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Washington UniversitySaint Louis, MO
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
References
[The use of Marcaine in obstetrical analgesia]. [2013]Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.
Bupivacaine: a review. [2018]A review of current significant literature concerning bupivacaine hydrochloride (Marcaine) is presented with particular emphasis on clinical use in oral surgery. The major advantages compared with other presently used local anesthetics are an increased duration of action and a favorable potency to toxicity ratio.
Bupivacaine: a review of 11,080 cases. [2019]Bupivacaine (Marcaine) hydrochloride, a long-acting local anesthetic drug, was used in concentrations of 0.25, 0.5, or 0.75 percent with and without a vasoconstrictor, in amounts ranging from 25 to over 600 mg, for caudal, epidural (peridural), or peripheral nerve block for 11,080 surgical, obstetrical, diagnostic, or therapeutic procedures. Onset of anesthesia occurred in 4 to 10 minutes and maximum anesthesia in 15 to 35 minutes. Concentrations of 0.25, 0.5, and 0.75 percent consistently produced complete sensory anesthesia of the integumentary and musculoskeletal systems. With 0.25 and 0.5 percent, motor blockade ranged from minimal to complete. In intra-abdominal surgery, only 0.75 percent consistently produced profound muscle relaxation. Fifteen systemic toxic reactions occurred, but no untoward sequelae resulted from them. One inadvertent subarachnoid injection of 110 mg resulted in a total spinal block with an uneventful recovery.
Postoperative pain relief using local anesthetic instillation. [2019]Effective pain control following surgery is a concern. Oral narcotic agents may be effective yet have many side effects. Parenteral agents are impractical in outpatient procedures. Local blocks may distort tissue planes and require additional time and technical skill to administer. We have found that instillation of local anesthetic (0.5% bupivacaine [Marcaine, Sensorcaine]) into the wound prior to closure is a safe and effective means of providing significant reduction in postoperative foot pain.
The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? [2018]A simple technique of wound perfusion with bupivacaine (Marcain) which provides sustained postoperative analgesia is described. No complications nor side effects related to toxicity, hypersensitivity, infection, or impaired wound healing were encountered. Postoperative pain was reduced and analgesic requirements were significantly lower in patients undergoing both intermittent (P less than 0.01) and continuous (P = 0.1) wound perfusion (Student t test). Perfusion with isotonic saline was also found to be effective. This may represent a true therapeutic effect attributable to the removal or dilution of pain mediating substances in the wound.
Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication.
Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]Bupivacaine (Marcaine), homologue of mepivacaine, chemically related to lidocaine, is used as a local anesthetic for local infiltration, peripheral nerve block, retrobulbar block, symphathetic block, and caudal and epidural anesthesia. The aim of this investigation was to determine and to compare clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor.
A Prospective Randomized Study Comparing Bupivacaine Hydrochloride Versus Bupivacaine Liposome for Pain Management After Distal Radius Fracture Repair Surgery. [2018]To compare pain experience and opioid use after distal radius fracture repair surgery performed with perioperative infiltration of the local anesthesia bupivacaine hydrochloride (Marcaine; Pfizer, New York, NY) or bupivacaine liposome (Exparel; Pacira, Parsippany, NJ).