Liposomal Bupivacaine vs Nerve Catheters for Post-Amputation Pain
Recruiting in Palo Alto (17 mi)
Overseen byRyan Mountjoy, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Ryan Mountjoy, MD
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.
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 on opioids over 90 MME/day, you cannot participate.
What data supports the idea that Liposomal Bupivacaine vs Nerve Catheters for Post-Amputation Pain is an effective treatment?
The available research shows that liposomal bupivacaine may help reduce the need for opioids after surgery. In a study on below knee amputations, patients who received liposomal bupivacaine nerve blocks used less opioids compared to those who did not receive it (25.0 vs 50.5 in daily opioid use). However, other studies suggest that liposomal bupivacaine does not consistently provide better pain relief than standard treatments. For example, only a small percentage of trials showed significant improvement with liposomal bupivacaine compared to other anesthetics. Overall, the evidence does not strongly support using liposomal bupivacaine over other options for post-amputation pain.
12345What safety data exists for liposomal bupivacaine?
Liposomal bupivacaine (Exparel) is approved for postsurgical analgesia and has been studied in various clinical trials. It is generally considered safe for surgical infiltration and peripheral nerve blocks, though its effectiveness compared to standard anesthetics is mixed. Some studies have examined its use in off-label applications, such as peripheral nerve blocks and subarachnoid injections, with varying outcomes. Overall, while it is approved and used in certain settings, its superiority over traditional bupivacaine is not consistently supported by evidence.
36789Is the drug Liposomal bupivacaine a promising treatment for post-amputation pain?
Liposomal bupivacaine, a drug used to manage pain after surgery, has shown mixed results in research. While it is safe and can reduce pain in some cases, most studies do not show it to be better than standard pain relief methods. Therefore, it may not be a promising treatment for post-amputation pain compared to other options.
123410Eligibility Criteria
This trial is for individuals scheduled for primary below-knee amputation or stump revision, who can understand and consent in English. They should not have a severe allergy to local anesthetics, infections where the needle will go, extreme obesity (BMI > 40), bleeding disorders, be on high-dose opioids (>90 MME/day), have substance use disorders, or need emergency amputations.Inclusion Criteria
English speaking
You have a certain level of physical health, as classified by the American Society of Anesthesiologists.
You are planning to have a surgery to remove a limb or revise the remaining part of a limb.
Exclusion Criteria
You have been diagnosed with a substance use disorder.
Patients unable to cooperate or consent to the study
You are allergic to local anesthetics.
+6 more
Participant Groups
The study compares two pain management methods after leg amputations: Liposomal bupivacaine versus continuous nerve catheters with Bupivacaine Hydrochloride. It's designed to gather initial data at Maine Medical Center to plan a larger future study.
2Treatment groups
Active Control
Group I: Continuous perineural popliteal nerve block catheterActive Control1 Intervention
Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2
Group II: Single Shot Perineural Popliteal Nerve BlockActive Control1 Intervention
Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery
Liposomal bupivacaine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Exparel for:
- Postsurgical pain in adults
🇪🇺 Approved in European Union as Exparel liposomal for:
- Local pain relief around small to medium-sized surgical wounds
- Regional pain relief in the surgery of the knee and around the shoulders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maine Medical CenterPortland, ME
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Who Is Running the Clinical Trial?
Ryan Mountjoy, MDLead Sponsor
MaineHealthCollaborator
References
Liposomal bupivacaine in forefoot surgery. [2022]Liposomal bupivacaine is increasingly being utilized in attempts to provide prolonged local analgesia in the immediate postoperative period. The purpose of this study was to quantify the reduction in opioid consumption as well as postoperative pain scores in the postoperative period when liposomal bupivacaine is used at the conclusion of forefoot surgery.
Peripheral Nerve Blockade with Combined Standard and Liposomal Bupivacaine in Major Lower-Extremity Amputation. [2022]Optimizing perioperative analgesia for patients undergoing major lower-extremity amputation remains a considerable challenge. The utility of liposomal bupivacaine as a component of peripheral nerve blockade for lower-extremity amputation is unknown.
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.
Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. [2020]To study the effects of liposomal bupivacaine (LB) compared with bupivacaine hydrochloride with lidocaine on postoperative day 1 pain scores.
The Efficacy of Liposomal Bupivacaine in Regional Nerve Blocks for Below Knee Amputations. [2023]Postamputation pain is highly prevalent. Opioids are often utilized postoperatively; however, they have significant side effects. Liposomal bupivacaine (LB) was introduced to extend nerve blocks from hours into days. Regional nerve blocks with LB for below knee amputation (BKA) is a novel approach which may reduce opioid use after surgery. A retrospective review was conducted for patients who had received LB nerve blocks compared to none for postoperative pain control in BKAs. Daily average opioid consumption was evaluated from the time in postoperative acute care unit until day of discharge in oral morphine equivalents (OME). 69 patients who underwent below knee amputations were reviewed. The mean average daily OME was lower in the LB group compared to control group(25.0 vs 50.5 OME, respectively; P = .002) A higher percentage of patients in the study group were categorized in the minimal opioid use when compared to the control group LB regional nerve blocks for the BKA population are considered a novel approach in pain control. Our exploratory study shows that patients who received LB nerve blocks may have decreased opioid consumption after surgery.
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.
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.
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.
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.
Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction. [2022]Patients undergoing mastectomy and prosthetic breast reconstruction have significant acute postsurgical pain, routinely mandating inpatient hospitalization. Liposomal bupivacaine (LB) (Exparel; Pacira Pharmaceuticals, Inc., Parsippany, N.J.) has been shown to be a safe and effective pain reliever in the immediate postoperative period and may be advantageous for use in mastectomy and breast reconstruction patients.