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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if bupivacaine HCl injections, a local anesthetic, can better control pain after skin surgery. Participants will receive either bupivacaine HCl or a saline injection during surgery to compare pain relief. They will keep a journal of their pain and any pain medications taken for three days, then share it with researchers during a follow-up visit. Individuals in good general health planning to have skin surgery in the Chicago area might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that bupivacaine HCl is likely to be safe for humans?

Research has shown that bupivacaine hydrochloride, the treatment under study, is generally well tolerated. Used since 1957 as a local anesthetic, studies have found it safe for skin surgeries. Although very high doses can affect the heart, the doses used in skin surgery, such as in this trial, are much lower, reducing the risk. Most people using bupivacaine for surgeries have not reported serious side effects. Overall, it is considered a reliable option for pain control after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard pain control options for postoperative skin surgery, which often include oral medications like opioids and NSAIDs, bupivacaine HCl is injected directly at the surgical site. This method provides targeted, long-lasting pain relief right where it's needed, potentially reducing the need for systemic pain medications that can have more widespread side effects. Researchers are excited about bupivacaine because it offers a local anesthetic solution that can minimize overall medication use and enhance recovery by focusing pain management precisely at the wound closure site.

What evidence suggests that bupivacaine HCl is effective for postoperative pain control after skin surgery?

This trial will compare the effectiveness of Bupivacaine Hydrochloride with a saline placebo for postoperative pain control after skin surgery. Studies have shown mixed results regarding bupivacaine's ability to reduce postoperative pain. One study found it effective during a specific type of skin surgery. However, another study indicated that bupivacaine didn't significantly reduce pain or the need for pain medication unless the surgery lasted more than 40 minutes. Some research also suggests that bupivacaine can aid in pain management during surgery when combined with other medications like epinephrine. Overall, bupivacaine might help with postoperative pain, but its effectiveness can depend on the type and duration of the surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37076252/

A randomized, double-blind, placebo-controlled study to ... This study examined the efficacy and safety of the bupivacaine implant (300 mg) compared with placebo for postsurgical pain after abdominoplasty ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7002882/

Effect of bupivacaine on postoperative pain and analgesics ... Bupivacaine did not decrease pain and analgesics use. When surgery exceeded 40 minutes, bupivacaine use might be associated with less pain and less analgesics ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04362566?tab=table

NCT04362566 | Bupivacaine for Post-operative Pain in Mohs In addition, a recent study has showed subcutaneous infiltration of bupivacaine with epinephrine to be an effective intra-operative pain adjuvant during MMS ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949962325000105

Comparing intraoperative administration of long-acting ... This study compared postoperative pain outcomes with LB versus MCs such as ropivacaine-epinephrine-clonidine-ketorolac, bupivacaine-epinephrine-dexamethasone, ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ... Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532883/

Bupivacaine - StatPearls - NCBI Bookshelf - NIH Bupivacaine is a potent local anesthetic with unique characteristics from the amide group of local anesthetics, first discovered in 1957.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10646917/

A randomized, double-blind, placebo-controlled study to ... This study examined the efficacy and safety of the bupivacaine implant (300 mg) compared with placebo for postsurgical pain after abdominoplasty.

8. nature.com nature.com/articles/s41598-025-17790-9

Preclinical safety and feasibility of a bupivacaine-loaded ... Pain and side effects of analgesics hinder postoperative recovery after instrumented spine surgery. Current locoregional blocks and ...