75 Participants Needed

Liposomal Bupivacaine vs Lidocaine for Skin Graft Pain

JR
DB
Overseen ByDhaval Bhavsar, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug liposomal bupivacaine for skin graft pain?

Research shows that liposomal bupivacaine can provide pain relief for up to 72 hours after skin graft procedures, which is longer than traditional local anesthetics. This sustained-release effect helps manage pain more effectively at the donor site.12345

Is liposomal bupivacaine generally safe for humans?

Liposomal bupivacaine is a local anesthetic that provides long-lasting pain relief and has been studied for its safety in various surgical settings. It has a favorable potency to toxicity ratio, meaning it is effective without being overly harmful, but there are concerns about potential nerve toxicity, especially when injected into nerves.14678

How does liposomal bupivacaine differ from lidocaine for skin graft pain?

Liposomal bupivacaine is unique because it provides long-lasting pain relief for up to 72 hours after a single dose, unlike traditional local anesthetics like lidocaine, which have a shorter duration of action. This makes it particularly useful for managing the intense pain associated with skin graft donor sites.123910

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.

Inclusion Criteria

You have less than 20% of your body surface area burned, with less than 5% of that being deep burns.
Spanish/English speaking

Exclusion Criteria

Burns on the front of the thighs.
Pregnant
You have a long-lasting pain condition.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Randomized controlled study with injection of lidocaine with epinephrine or liposomal bupivacaine at the donor site

1 day
1 visit (in-person)

Treatment Phase 2

All subjects receive regional anesthesia with a nerve block based on the proposed donor site location

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain levels and opioid consumption post-operatively

3 days
Pain assessments at 4, 8, 12, 24, 48, and 72 hours post-operatively

Treatment Details

Interventions

  • Bupivacaine Hydrochloride
  • Lidocaine Hydrochloride
  • Liposomal bupivacaine
Trial OverviewThe 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

Findings from Research

In a study of 58 patients undergoing skin graft procedures, those who received liposomal bupivacaine reported significantly lower donor site pain on postoperative days 0 and 1, with 86% rating their pain as three or less, compared to only 3.4% in the control group.
Liposomal bupivacaine not only reduced pain levels but also made the donor site less bothersome for patients, with 76% stating it was less painful than the graft site, indicating its potential as a safe and effective option for prolonged postoperative analgesia.
Intraoperative liposomal bupivacaine for skin graft donor site analgesia: A retrospective cohort study.Artz, C., Ward, MA., Miles, MVP., et al.[2021]
Liposomal formulations of local anesthetics (prilocaine, lidocaine, and mepivacaine) significantly enhanced their anesthetic effects and prolonged recovery times compared to plain solutions, with mepivacaine showing the greatest improvement.
The study demonstrated that liposomes can serve as effective drug-delivery systems for local anesthetics, suggesting potential for better pain management in clinical settings.
Liposomal formulations of prilocaine, lidocaine and mepivacaine prolong analgesic duration.Cereda, CM., Brunetto, GB., de Araújo, DR., et al.[2022]
Liposomal formulations of local anesthetics (prilocaine, lidocaine, and mepivacaine) significantly enhanced the anesthetic effect and prolonged recovery time compared to plain solutions, with mepivacaine showing the greatest improvement.
The study demonstrated that liposomes are effective drug-delivery systems for local anesthetics, although lidocaine benefited the least from encapsulation, likely due to its stronger vasodilatory effects.
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].Saia Cereda, CM., Brunetto, GB., de Araújo Phd, DR., et al.[2022]

References

Intraoperative liposomal bupivacaine for skin graft donor site analgesia: A retrospective cohort study. [2021]
Liposomal formulations of prilocaine, lidocaine and mepivacaine prolong analgesic duration. [2022]
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]
Bupivacaine: a review. [2018]
Evaluation of Liposomal Bupivacaine at Split-Thickness Skin Graft Donor Sites Through a Randomized, Controlled Trial. [2022]
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]
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]
Neurotoxicity of intraneural injection of bupivacaine liposome injectable suspension versus bupivacaine hydrochloride in a porcine model. [2019]
Liposomal bupivacaine for the management of postsurgical donor site pain in patients with burn injuries: a case series from two institutions. [2021]
Evaluation of liposomal bupivacaine infiltration at reconstructive skin graft donor sites in adolescent and young adult burn patients: A retrospective analysis. [2022]