Peripheral Nerve Blocks for Amputations
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
No Placebo Group
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using opioids chronically, you cannot participate in the trial.
What data supports the idea that Peripheral Nerve Blocks for Amputations is an effective treatment?The available research shows that Peripheral Nerve Blocks (PNBs) can be an effective treatment for lower limb amputations. One study highlights that PNBs can be used as an alternative anesthetic technique for high-risk patients undergoing amputations, suggesting they are a viable option when other methods might pose more risk. Another study indicates that PNBs are increasingly popular for controlling pain after surgery, especially with the use of certain medications that prevent blood clots. Additionally, a comparison between PNBs and general anesthesia for lower extremity amputations in Japan suggests that PNBs may offer health benefits in terms of reducing postoperative complications. Overall, these studies support the effectiveness of PNBs in managing pain and potentially improving outcomes for patients undergoing amputations.2361012
Is Peripheral Nerve Block a promising treatment for amputations?Yes, Peripheral Nerve Block is a promising treatment for amputations. It is used as an alternative to traditional anesthesia, especially in high-risk patients, and helps manage pain during and after surgery. It has been successfully used in patients with severe health issues, keeping them stable during operations.456812
What safety data exists for peripheral nerve blocks used in amputations?Peripheral nerve blocks (PNBs) are generally considered safe and effective for pain management, but they do carry risks such as local nerve damage and systemic toxicity. These risks can be minimized with careful injection techniques and understanding of potential complications. Studies, including a multicenter audit of over 7000 blocks, have shown that while PNBs are associated with excellent outcomes, they can also lead to neurologic and other complications. Techniques and tools like nerve stimulators and anatomical landmarks are used to improve safety and success rates. The economic burden of adverse events from PNBs is also a concern, highlighting the importance of careful management.1791113
Eligibility Criteria
This trial is for patients needing above-the-knee amputations who can understand and agree to the study. It's not for those with chronic opioid use, severe liver issues, a BMI over 35, sensorimotor deficits, or true allergies to local anesthetics or sedatives.Inclusion Criteria
I am having an amputation above my knee.
Exclusion Criteria
I have severe liver problems.
My BMI is 35 or higher.
I cannot or do not want to give permission for treatment.
I have an infection where they might insert a needle.
I regularly use opioid medication.
Participant Groups
The study tests if using nerve blocks and sedatives during surgery offers better safety and pain control than general anesthesia in patients with conditions like diabetes, high blood pressure, heart disease, COPD.
1Treatment groups
Experimental Treatment
Group I: Peripheral nerve blockExperimental Treatment4 Interventions
Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations.
All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.
Peripheral Nerve Block is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Peripheral Nerve Block for:
- Pain control after fracture surgery
- Postoperative pain management
- Chronic pain management
🇺🇸 Approved in United States as Peripheral Nerve Block for:
- Pain control after fracture surgery
- Postoperative pain management
- Chronic pain management
- Acute pain management
🇨🇦 Approved in Canada as Peripheral Nerve Block for:
- Pain control after fracture surgery
- Postoperative pain management
- Chronic pain management
🇯🇵 Approved in Japan as Peripheral Nerve Block for:
- Pain control after fracture surgery
- Postoperative pain management
🇦🇺 Approved in Australia as Peripheral Nerve Block for:
- Pain control after fracture surgery
- Postoperative pain management
- Chronic pain management
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who is running the clinical trial?
University of FloridaLead Sponsor
US Department of Veterans AffairsCollaborator
References
[Optimal use of peripheral nerve blocks]. [2013]The advantages of regional over general anaesthesia have led to an increased use of peripheral nerve blocks. Among the few risks of regional anaesthesia are those of overdosage, systemic and neural toxicity. Techniques have been proposed to improve the success of peripheral nerve blocks and to avoid nerve damage or systemic toxicity. Nerve stimulator, anatomic landmarks, needles and anaesthetic solutions are discussed.
Local and regional block in postoperative pain control. [2019]Local and regional block provides an effective means for the control of postoperative pain. In surgery involving the trunk, it serves as a useful alternative to epidural analgesia. With the increasing use of low molecular weight heparin, the use of peripheral nerve block is increasingly popular for patients undergoing lower limb surgery.
[Peripheral nerve block for surgical anesthesia and postoperative analgesia of the legs]. [2009]Even though peripheral nerve blocks (PNB) on the lower limb offer advantages over neuroaxial blockades and general anesthesia, their use has not been fully established. The infrequency with which PNBs are used may be due to inadequate learning, the need to make several injections, the time until onset of block, or anesthesiologists' and surgeons' lack of familiarity with the benefits of regional blocks. Interest seems to have increased in recent years, as numerous publications have focused on lower limb PNBs for surgery and postoperative analgesia. Our aim was to review the main approaches used and the indications for each.
Lower extremity nerve blocks. [2019]The purpose of this review is to present the most important recent studies into the clinical use of peripheral nerve blocks for anesthesia and postoperative analgesia of the lower limb surgery.
The successful use of peripheral nerve blocks for femoral amputation. [2022]We present a case report of four patients with severe cardiac insufficiency where peripheral nerve blocks guided by either nerve stimulation or ultrasonography were the sole anaesthetic for above-knee amputation. The patients were breathing spontaneously and remained haemodynamically stable during surgery. Thus, use of peripheral nerve blocks for femoral amputation in high-risk patients seems to be the technique of choice that can lower perioperative risk.
A preliminary report on the use of peripheral nerve blocks for lower limb amputations. [2022]To determine whether there are any advantages of using peripheral nerve blocks as an anaesthetic technique for patients undergoing lower limb amputations.
Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. [2022]Peripheral nerve blockade is associated with excellent patient outcomes after surgery; however, neurologic and other complications can be devastating for the patient. This article reports the development and preliminary results of a multicenter audit describing the quality and safety of peripheral nerve blockade.
A survey of emergency medicine and orthopaedic physicians' knowledge, attitude, and practice towards the use of peripheral nerve blocks. [2022]Peripheral nerve blocks (also known as regional anaesthesia) are currently used by many anaesthesiologists and emergency physicians for perioperative and procedural pain management.
Novel Regional Anesthesia for Outpatient Surgery. [2020]Peripheral nerve blocks are effective and safe modalities for perioperative analgesia. But it remains unclear what blocks are adequate for ambulatory surgeries, as well as the proper patient management before and after discharge.
Comparing outcomes after peripheral nerve block versus general anesthesia for lower extremity amputation: a nationwide exploratory retrospective cohort study in Japan. [2022]The health benefits of peripheral nerve block (PNB) on postoperative complications after lower extremity amputation (LEA) compared with general anesthesia (GA) remains controversial. We performed a retrospective propensity score-matched cohort analysis to compare major outcomes after LEA with PNB versus GA.
Identification and economic burden of main adverse events of nerve injuries caused by regional anesthesia: a systematic review. [2023]Anesthesiologists and hospitals are increasingly confronted with costs associated with the complications of Peripheral Nerve Blocks (PNB) procedures. The objective of our study was to identify the incidence of the main adverse events associated with regional anesthesia, particularly during anesthetic PNB, and to evaluate the associated healthcare and social costs.
The use of ultrasound guided combined peripheral nerve blocks in a high-risk patient: A case report. [2021]Combined peripheral nerve blocks can be used as an alternative anesthetic technique for lower limb amputations in high-risk patients. The approach may vary according to the clinical condition of the patient. Presently described is the use of a combination of peripheral nerve blocks used for above-the-knee amputation in a high-risk patient: a sciatic nerve block with an anterior approach, a femoral nerve block, and a lateral femoral cutaneous nerve block.
Regional Anesthesia for Orthobiologic Procedures. [2022]Peripheral nerve blocks (PNB) can lessen procedural pain and eliminate the known detrimental effects of our local anesthetics on our orthobiologic target tissues. Local nerve damage and local anesthetic systemic toxicity are risks of PNBs that can be minimized with meticulous injection technique and an understanding of why these complications can occur. Herein, several PNB techniques are described in an effort to enhance procedural safety, efficacy, and comfort.