Liposomal Bupivacaine vs Lidocaine for Skin Graft Pain
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Kansas Medical Center
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Donor site pain study comparing post-operative donor site pain and opioid consumption after use of Lidocaine, Liposomal Bupivicaine or regional nerve block for split thickness skin graft harvesting in patients with less than 20% TBSA burn wounds and less than %5 Deep partial or full thickness burn wounds.
Is liposomal bupivacaine a promising drug for reducing pain after skin grafts?Yes, liposomal bupivacaine is a promising drug because it provides long-lasting pain relief for up to 72 hours after skin graft procedures, which can help manage intense pain effectively.234710
What safety data exists for liposomal bupivacaine and lidocaine in treating skin graft pain?Liposomal bupivacaine, a sustained-release formulation, has been studied for its efficacy in postoperative pain control at skin graft donor sites, showing potential for prolonged analgesia. Safety data includes a study on its use in surgical infiltration anesthesia, which analyzed nerve toxicity and effectiveness, and a comparison of its neurotoxicity to standard bupivacaine hydrochloride in a porcine model. Additionally, a pilot study compared its effectiveness in reducing postoperative pain and opioid use to bupivacaine hydrochloride in lingual nerve surgery. These studies suggest a favorable potency to toxicity ratio for bupivacaine, but specific safety data for lidocaine in this context is not detailed in the provided research.15679
What data supports the idea that Liposomal Bupivacaine vs Lidocaine for Skin Graft Pain is an effective treatment?The available research shows that Liposomal Bupivacaine is effective for managing pain at skin graft donor sites. One study highlights that it provides pain relief for up to 72 hours, which is longer than traditional local anesthetics like Lidocaine. Another study, a randomized controlled trial, found that Liposomal Bupivacaine reduced pain and the need for additional pain medication in patients who had skin grafts. This suggests that Liposomal Bupivacaine is a more effective option for prolonged pain relief compared to Lidocaine.12378
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications.
Eligibility Criteria
This trial is for English or Spanish speakers with less than 20% total body surface area (TBSA) burned and less than 5% deep partial/full thickness burns. It's not for those with chronic pain conditions, more extensive burns, pregnancy, or allergies to local anesthetics like lidocaine.Treatment Details
The study compares the effectiveness of Lidocaine, Liposomal Bupivacaine, and regional nerve block in managing post-operative pain at skin graft donor sites in burn patients. It also looks at how these treatments affect opioid use after surgery.
3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3Experimental Treatment1 Intervention
Subjects will receive regional anesthesia with a bupivacaine nerve block; either a fascia iliaca, lateral femoral cutaneous, or femoral nerve block based on the proposed donor site location
Group II: Group 1Experimental Treatment1 Intervention
Liposomal Bupivicaine (266mg/20ml) will be diluted into Lactated Ringer solution (280 ml) and injected once intra-operatively subcutaneously before donor site harvesting
Group III: Group 2Active Control1 Intervention
Lidocaine (50 mg/50 ml) will be diluted into Lactated Ringer (1000ml) and injected once subcutaneously before donor site harvesting
Find a clinic near you
Research locations nearbySelect from list below to view details:
The University of Kansas Health SystemKansas City, KS
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
References
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.
Liposomal formulations of prilocaine, lidocaine and mepivacaine prolong analgesic duration. [2022]A laboratory investigation was undertaken to compare the in vivo antinociceptive effects of 2% liposomal formulations of prilocaine (PLC), lidocaine (LDC) and mepivacaine (MVC) compared to plain solutions of each of these three local anesthetics.
Liposomal formulations of prilocaine, lidocaine and mepivacaine prolong analgesic duration : [Des préparations liposomiques de prilocaïne, de lidocaïne et de mépivacaïne prolongent la durée de l'analgésie]. [2022]A laboratory investigation was undertaken to compare the in vivo antinociceptive effects of 2% liposomal formulations of prilocaine (PLC), lidocaine (LDC) and mepivacaine (MVC) compared to plain solutions of each of these three local anesthetics.
Liposomal bupivacaine for the management of postsurgical donor site pain in patients with burn injuries: a case series from two institutions. [2021]Donor site pain associated with skin graft procedures is frequently intense and difficult to treat. Liposomal bupivacaine, a prolonged-release local anesthetic indicated for single-dose administration to produce postsurgical analgesia, may be a viable option in managing donor site pain.
Neurotoxicity of intraneural injection of bupivacaine liposome injectable suspension versus bupivacaine hydrochloride in a porcine model. [2019]To test whether neurotoxic effects of a bupivacaine liposome injectable suspension differ from those of a standard formulation of bupivacaine hydrochloride (HCl) after intraneural injection into the sciatic nerves in pigs.
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.
Intraoperative liposomal bupivacaine for skin graft donor site analgesia: A retrospective cohort study. [2021]Burn injury and reconstructive operations often result in severe pain, particularly at skin graft donor sites. Traditional local anesthetics administered intraoperatively control pain at donor sites, but the duration of action is short. Liposomal bupivacaine, a novel local anesthetic, can provide sustained-release analgesia for 72h. The primary aim of this study was to describe the efficacy of liposomal bupivacaine for postoperative donor site pain control for patients undergoing skin graft procedures.
Evaluation of Liposomal Bupivacaine at Split-Thickness Skin Graft Donor Sites Through a Randomized, Controlled Trial. [2022]Split-thickness skin grafts (STSG) are commonly required in reconstructive surgery but may cause significant pain. The goal of this investigator-initiated trial is to evaluate the effect of liposomal bupivacaine on donor site pain and opioid consumption. A parallel, randomized, controlled trial of adult acute burn patients with
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.
Evaluation of liposomal bupivacaine infiltration at reconstructive skin graft donor sites in adolescent and young adult burn patients: A retrospective analysis. [2022]Postoperative pain at skin graft donor sites is frequently undertreated in burn patients, which can impair reconstructive outcomes and result in harmful psychological consequences. We find a critical need to explore and promote non-opioid, multimodal analgesics. Donor site infiltration of the local anesthetic liposomal bupivacaine in adolescent and young adult burn patients has not been previously investigated. Therefore, the goal of this study was to evaluate intraoperative liposomal bupivacaine infiltration for postoperative donor site pain control in adolescent and young adult burn patients undergoing reconstructive skin graft procedures.