Bupivacaine Hydrochloride for Postoperative Pain Control After Skin Surgery

Overseen By DermCTU

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Northwestern University

Disqualifiers: Allergy to bupivacaine, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

Trial Summary

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 organizers or your doctor.

What data supports the effectiveness of the drug Bupivacaine Hydrochloride for postoperative pain control after skin surgery?

Research shows that Bupivacaine Hydrochloride is effective in providing pain relief after surgeries, such as oral and maxillofacial surgery, and reduces the need for opioids (strong painkillers) after spine surgery. It is also noted to provide greater pain relief compared to lidocaine, another common anesthetic. ^{1 2 3 4 5}

Is Bupivacaine Hydrochloride safe for humans?

Bupivacaine Hydrochloride, used in various forms like liposomal bupivacaine and implants, has been studied for safety in several clinical trials. These studies, including those on liposome bupivacaine, have generally shown it to be safe for managing postoperative pain in humans. ^{1 3 6 7 8}

How does bupivacaine hydrochloride differ from other drugs for postoperative pain control after skin surgery?

Bupivacaine hydrochloride is unique because it is a long-acting local anesthetic that provides extended pain relief compared to other anesthetics like lidocaine. Additionally, novel formulations like liposomal bupivacaine offer sustained release, potentially enhancing its duration of action for postoperative pain management. ^{1 2 6 7 9}

What is the purpose of this trial?

The purpose of this study is to determine if the addition of bupivacaine HCl injections will improve pain control after skin surgery. This is a randomized clinical trial. Approximately 100 participants will be randomized to receive either bupivacaine HCl or saline injections to help with the postsurgical pain. Patients will be provided with a take-home journal to complete indicating when and how much pain medication they required for the 3 days immediately following surgery. Participants will return the journal in-person at a follow up visit 7-21 days post-op. This study was a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults over 18 in good health who are undergoing skin surgery and live in the Chicago area. They must be able to communicate effectively and consent to participate. People can't join if they're pregnant, planning pregnancy, allergic to bupivacaine or similar anesthetics, have issues with narcotics, or have mental impairments.

Inclusion Criteria

I am undergoing skin surgery.

In good general health as assessed by the investigator

Exclusion Criteria

You are allergic to bupivacaine or similar types of anesthetics.

I can communicate and cooperate with my doctor without any issues.

You cannot take narcotic medication for medical reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bupivacaine HCl or saline injections immediately prior to surgical wound closure

1 day

1 visit (in-person)

Post-operative Monitoring

Participants complete a take-home journal for 3 days to report pain medication usage

3 days

Follow-up

Participants return the journal and are monitored for safety and effectiveness after treatment

1-3 weeks

1 visit (in-person)

Treatment Details

Interventions

• Bupivacaine Hydrochloride
• Skin Surgery

Trial Overview The study tests whether injecting Bupivacaine Hydrochloride after skin surgery provides better pain control than saline injections. Participants will record their pain medication use post-surgery for three days and report back within 7-21 days.

Participant Groups

Group I: Bupivacaine HCl Active Control 1 Intervention

Immediately prior to surgical wound closure, participants randomized to the bupivacaine arm will be injected with bupivacaine HCl along the closure site.

Group II: Saline Placebo Group 1 Intervention

Immediately prior to surgical wound closure, participants randomized to saline, will receive saline injections along the closure site.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

HYR-PB21-LA, a new microparticle suspension of bupivacaine pamoate, demonstrated significantly longer-lasting local anesthesia effects compared to traditional bupivacaine hydrochloride, lasting up to five times longer in animal tests.

In head-to-head comparisons, HYR-PB21-LA showed superior efficacy over liposomal bupivacaine, providing effective pain relief for up to 8 hours versus just 1 hour with the liposomal formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYR-PB21-LA, a potential extended-release bupivacaine formulation, produces long-lasting local anesthesia in rats and guinea pigs. Peng, J., Liu, C., Liu, J., et al.[2021]

0.5% bupivacaine hydrochloride offers superior pain relief compared to 2% lidocaine in oral and maxillofacial surgery, indicating its effectiveness as a local anesthetic.

The use of bupivacaine comes with only a minimal increase in cost for the surgeon, making it a cost-effective option for enhanced analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the analgesic efficacy and cost-effective use of long-acting local anesthetics in outpatient third molar surgery. Neal, JA., Welch, TB., Halliday, RW.[2019]

Intraoperative infiltration of bupivacaine during posterior spine surgery significantly reduced opioid consumption in the 72 hours post-surgery, indicating its efficacy as a pain relief adjunct.

Patients receiving bupivacaine also reported slightly lower pain scores and had better heart rate control, with no complications or significant increase in surgical time or hospital stay, highlighting its safety and practicality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradermal and Intramuscular Bupivacaine Reduces Opioid Use Following Noninstrumented Spine Surgery. Cleary, DR., Tan, H., Ciacci, J.[2023]

The bupivacaine implant (XARACOLL) significantly reduced pain intensity in the first 24 hours after abdominoplasty compared to placebo, indicating its efficacy in providing postoperative analgesia.

Patients receiving the bupivacaine implant had a higher percentage of opioid-free patients at 24, 48, and 72 hours post-surgery, suggesting it may help reduce reliance on opioids for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. Beaton, AC., Solanki, D., Salazar, H., et al.[2023]

In a study involving 823 patients across various surgical settings, liposome bupivacaine demonstrated a lower incidence of adverse events (62%) compared to bupivacaine HCl (75%) and placebo (43%), indicating better tolerability.

Serious adverse events were less common in the liposome bupivacaine group (2.7%) compared to bupivacaine HCl (5.4%), suggesting that liposome bupivacaine may be a safer option for local analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. Viscusi, ER., Sinatra, R., Onel, E., et al.[2022]

Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

HYR-PB21-LA, a potential extended-release bupivacaine formulation, produces long-lasting local anesthesia in rats and guinea pigs. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Analysis of the analgesic efficacy and cost-effective use of long-acting local anesthetics in outpatient third molar surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intradermal and Intramuscular Bupivacaine Reduces Opioid Use Following Noninstrumented Spine Surgery. [2023]

4. South Africa pubmed.ncbi.nlm.nih.gov

The efficacy of two bupivacaine hydrochloride injection products. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of continuous wound infusion of local anesthetics after abdominal surgeries. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of liposome bupivacaine, a novel local analgesic formulation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]