Nerve Block for Pain Management
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byMorgan Ritz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Disqualifiers: Unstable vitals, Infection, Pregnancy, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion
Will 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.
What data supports the effectiveness of the drug Bupivacaine Injection, including its formulations like Exparel, for pain management?
Research shows that liposomal bupivacaine (Exparel) can provide extended pain relief after surgery, but its effectiveness compared to standard bupivacaine is mixed. Some studies found it less effective than regular bupivacaine for nerve blocks, while others noted potential benefits in reducing pain and opioid use after certain surgeries.
12345Is liposomal bupivacaine (Exparel) safe for use in nerve blocks?
Liposomal bupivacaine (Exparel) has been shown to be safe in clinical trials for use in peripheral nerve blocks and other procedures, with minimal side effects when used as directed. It is approved for use in surgical sites to manage pain, and studies suggest it has a good safety profile.
23678How is the drug Bupivacaine Injection unique for pain management?
Bupivacaine Injection, particularly in its liposomal form (Exparel), is unique because it is designed to provide extended pain relief by slowly releasing the anesthetic over time, which can reduce the need for additional pain medications like opioids. This formulation is particularly used for managing pain after surgery and has been explored for off-label use in peripheral nerve blocks.
238910Eligibility Criteria
This trial is for adults with certain painful conditions like rib or vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain. It's not suitable for those with unstable vital signs, skin infections at the injection site, allergies to local anesthetics, pregnant women or individuals under 18.Inclusion Criteria
I have had severe kidney pain.
I am experiencing back pain.
I have had fractures in my ribs or spine.
+1 more
Exclusion Criteria
My vital signs are not stable.
I am under 18 years old.
Prior allergic reaction to local anesthetic
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
Treatment
Participants receive an erector spinae plane block (ESPB) under ultrasound guidance for pain control
30 minutes
1 visit (in-person)
Follow-up
Participants are monitored for pain relief and opiate use after the procedure
8 hours
Participant Groups
The study tests if injecting Bupivacaine into the erector spinae muscles can help manage pain from specific conditions and reduce the need for opioid painkillers after treatment.
1Treatment groups
Experimental Treatment
Group I: Erector Spinae Plane Block (ESP) administrationExperimental Treatment1 Intervention
Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.
Bupivacaine Injection is already approved in United States, European Union, United States, United States for the following indications:
🇺🇸 Approved in United States as Marcaine for:
- Local Anesthesia
- Postoperative Pain
- Cesarean Section
- Epidural Anesthesia
- Caudal Blocks
- Sympathetic Nerve Block
- Peripheral Nerve Block
🇪🇺 Approved in European Union as Sensorcaine for:
- Local Anesthesia
- Regional Anesthesia
- Pain Management
🇺🇸 Approved in United States as Posimir for:
- Post-surgical Analgesia for up to 72 hours following arthroscopic subacromial decompression
🇺🇸 Approved in United States as Xaracoll for:
- Acute postsurgical analgesia for up to 24 hours in adults following open inguinal hernia repair
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Crozer Chester Medical CenterUpland, PA
Baylor Scott & WhiteTemple, TX
Crozer Chester Medical CenterRidley Park, PA
University HospitalSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. [2017]Medical studies have shown some potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA), a slow-release bupivacaine solution, to extend postoperative benefits of numbness/pain relief for up to several days. Because the Food and Drug Administration has approved Exparel only for infiltrations, we wanted to evaluate if it would be effective as an infiltration to control postoperative pain. The purpose of this study was to compare an infiltration of bupivacaine with liposomal bupivacaine for postoperative numbness and pain in symptomatic patients diagnosed with pulpal necrosis experiencing moderate to severe preoperative pain.
Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. [2021]The purpose of this study was to determine if liposomal bupivacaine 1.3% (LB), Exparel (Pacira Pharmaceuticals), is more effective than bupivacaine hydrochloride 0.25% (BH), Marcaine (Hospira), in reducing postoperative pain and opioid consumption in patients undergoing exploratory lingual nerve microsurgery. The investigators hypothesized that patients who received LB would have a greater reduction in acute postoperative pain, and therefore, a reduction in total opioid use over 72 hours postoperatively.
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]The authors provide a comprehensive summary of all randomized, controlled trials (n = 76) involving the clinical administration of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, USA) to control postoperative pain that are currently published. When infiltrated surgically and compared with unencapsulated bupivacaine or ropivacaine, only 11% of trials (4 of 36) reported a clinically relevant and statistically significant improvement in the primary outcome favoring liposomal bupivacaine. Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine. Results were mixed for the 16 trials comparing liposomal and unencapsulated bupivacaine, both within peripheral nerve blocks. Overall, of the trials deemed at high risk for bias, 84% (16 of 19) reported statistically significant differences for their primary outcome measure(s) compared with only 14% (4 of 28) of those with a low risk of bias. The preponderance of evidence fails to support the routine use of liposomal bupivacaine over standard local anesthetics.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting.
[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.
Treatment of digital ischemia with liposomal bupivacaine. [2021]Objective. This report describes a case in which the off-label use of liposomal bupivacaine (Exparel) in a peripheral nerve block resulted in marked improvement of a patient's vasoocclusive symptoms. The vasodilating and analgesic properties of liposomal bupivacaine in patients with ischemic symptoms are unknown, but our clinical experience suggests a role in the management of patients suffering from vasoocclusive disease. Case Report. A 45-year-old African American female was admitted to the hospital with severe digital ischemic pain. She was not a candidate for any vascular surgical or procedural interventions. Two continuous supraclavicular nerve blocks were placed with modest clinical improvement. These effects were also short-lived, with the benefits resolving after the discontinuation of the peripheral nerve blocks. She continued to report severe pain and was on multiple anticoagulant medications, so a decision was made to perform an axillary nerve block using liposomal bupivacaine (Exparel) given the compressibility of the site as well as the superficial nature of the target structures. Conclusions. This case report describes the successful off-label usage of liposomal bupivacaine (Exparel) in a patient with digital ischemia. Liposomal bupivacaine (Exparel) is currently FDA approved only for wound infiltration use at this time.
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.
Perineural Liposomal Bupivacaine Is Not Superior to Nonliposomal Bupivacaine for Peripheral Nerve Block Analgesia. [2021]Liposomal bupivacaine is purported to extend analgesia of peripheral nerve blocks when administered perineurally. However, evidence of the clinical effectiveness of perineural liposomal bupivacaine is mixed. This meta-analysis seeks to evaluate the effectiveness of perineural liposomal bupivacaine in improving peripheral nerve block analgesia as compared with nonliposomal local anesthetics.