Local Anesthesia for Vaginal Lacerations

(PAIN Trial)

Recruiting at 1 trial location

Overseen By Alyssa M Yeung, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must be taking: Epidural analgesia

Disqualifiers: Operative delivery, Multiple gestation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain for women who have just given birth and require stitches for vaginal tears. Researchers aim to determine if using a local anesthetic, bupivacaine with epinephrine, can reduce pain and improve satisfaction compared to a regular saline solution. The study includes women with a working epidural during their repair who have not experienced complications like heavy bleeding or extreme pain. Participants should speak English or Spanish and have had a single baby. The goal is to help new mothers feel better and reduce the need for stronger pain medications. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Bupivacaine with Epinephrine?

Research shows that bupivacaine with epinephrine is generally safe for people. It often numbs areas during surgery, childbirth, and dental work, indicating its frequent use in similar situations. Studies have found it is usually well-tolerated, especially in childbirth-related care, with few side effects reported in these settings.

However, specific information on its effects on a baby's development during pregnancy is lacking. Doctors do not fully understand its impact on a baby's growth when used during pregnancy. Overall, existing evidence suggests it is safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using bupivacaine with epinephrine for treating vaginal lacerations because it offers a longer-lasting anesthesia effect compared to standard treatments like lidocaine. Bupivacaine is known for its prolonged duration of pain relief, which can be particularly beneficial in managing discomfort from lacerations. The addition of epinephrine helps to minimize bleeding and prolongs the anesthetic effect by constricting blood vessels. This combination could offer better pain management and efficiency in clinical settings, making it a promising option for improving patient care.

What evidence suggests that bupivacaine with epinephrine is effective for postpartum perineal pain?

In this trial, participants in the local anesthesia arm will receive bupivacaine with epinephrine. Research shows this combination effectively numbs the area during cuts or tears that need stitching. Bupivacaine stops pain, while epinephrine prolongs its effect by slowing blood flow at the application site. Studies indicate that adding epinephrine extends pain relief duration, which is beneficial after childbirth. Bupivacaine is already widely used in surgeries to numb specific areas, suggesting it could also manage pain post-childbirth. This treatment has reduced the need for opioid painkillers, helping to avoid their side effects or risk of dependency. ^{1 2 4 6 7}

Who Is on the Research Team?

Fatima Estrada, MD, FACOG

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy women over 18 who've had a single baby delivered vaginally, resulting in a second-degree perineal tear. They must speak English or Spanish and be able to consent for themselves. It's not specified who can't join.

Inclusion Criteria

My epidural is working during my laceration repair.

Healthy with a singleton pregnancy

I can make my own medical decisions.

Exclusion Criteria

Allergic to bupivacaine and/or epinephrine

I received a combined spinal-epidural anesthesia.

Multiple gestation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either bupivacaine with epinephrine or a saline sham injection for perineal laceration repair

Immediate

1 visit (in-person)

Immediate Follow-up

Participants' pain levels and time to first analgesic demand are assessed immediately and up to 24 hours after treatment

24 hours

Continuous monitoring

Follow-up

Maternal satisfaction and pain levels are assessed 48 hours after treatment

48 hours

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine with Epinephrine

Trial Overview The study tests if injecting bupivacaine with epinephrine reduces pain better than a fake (saline) injection after epidural anesthesia wears off post-vaginal delivery. Women are randomly assigned to either the real drug or sham treatment without knowing which one they receive.

How Is the Trial Designed?

Group I: Local Anesthesia arm Experimental Treatment 2 Interventions

Bupivicaine and Epinephrine

Group II: Normal saline sham arm Placebo Group 1 Intervention

Bupivacaine with Epinephrine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Bupivacaine with Epinephrine for:

• Local anesthesia for surgical procedures
• Pain relief for dental procedures
• Regional anesthesia for childbirth

Approved in European Union as Bupivacaine with Epinephrine for:

• Local anesthesia for surgical procedures
• Pain relief for dental procedures
• Regional anesthesia for childbirth
• Postoperative pain management

Approved in Canada as Bupivacaine with Epinephrine for:

• Local anesthesia for surgical procedures
• Pain relief for dental procedures
• Regional anesthesia for childbirth

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

In a randomized, double-blind study comparing 1% lidocaine with epinephrine to 0.5% bupivacaine with epinephrine for facial plastic surgery, bupivacaine demonstrated effective and safe anesthesia.

Bupivacaine, being a longer-acting local anesthetic, may provide better surgical conditions compared to lidocaine, making it a suitable choice for facial procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. Maimon, WN., Schuller, DE.[2022]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

In a study involving 90 children with mucous membrane lacerations, the traditional lidocaine infiltration was found to be significantly more effective than the new topical anesthetic TetraLidoPhen in reducing pain during suturing, as measured by various pain scales.

Despite TetraLidoPhen being statistically inferior to lidocaine, it was deemed safe for use on mucous membranes, with a low wound complication rate of 4.4%, suggesting that further research is needed to fully assess its clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetracaine-lidocaine-phenylephrine topical anesthesia compared with lidocaine infiltration during repair of mucous membrane lacerations in children. Smith, GA., Strausbaugh, SD., Harbeck-Weber, C., et al.[2017]

In a study involving 48 pediatric patients aged 7 to 17 with simple lacerations, applying a topical anesthetic gel (LET) three times at 10-minute intervals did not result in lower pain scores during suturing compared to a single application for 30 minutes.

Both treatment methods showed similar efficacy, with no significant difference in the need for additional anesthesia, indicating that the triple application does not provide a clear advantage over the single application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triple Versus Single Application of Lidocaine, Epinephrine, and Tetracaine for Laceration Repair in Children. Siembieda, J., Heyming, T., Padlipsky, P., et al.[2023]

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]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 183 adult patients with simple lacerations, 1% lidocaine provided significantly lower pain ratings during suturing compared to 2% prilocaine and buffered 1% lidocaine, indicating it may be the most effective local anesthetic for this procedure.

While all three anesthetics showed similar pain levels during the initial injection, 1% lidocaine resulted in the least pain during the actual suturing process, suggesting it may enhance patient comfort during laceration repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prilocaine versus plain or buffered lidocaine for local anesthesia in laceration repair: randomized double-blind comparison. Karcioglu, O., Topacoglu, H., Ayrik, C., et al.[2013]

In a study involving 180 children with lacerations requiring suturing, the new topical anesthetic prilocaine-phenylephrine was found to be effective and safer than the traditional TAC (tetracaine-adrenaline-cocaine) anesthetic, with no significant pain difference reported by patients.

While both prilocaine-phenylephrine and bupivacaine-phenylephrine were effective, prilocaine-phenylephrine statistically outperformed bupivacaine-phenylephrine, making it a promising alternative for laceration repair in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prilocaine-phenylephrine and bupivacaine-phenylephrine topical anesthetics compared with tetracaine-adrenaline-cocaine during repair of lacerations. Smith, GA., Strausbaugh, SD., Harbeck-Weber, C., et al.[2019]

Buffered lidocaine with epinephrine and plain lidocaine with epinephrine were found to be more effective anesthetics for suturing minor lacerations compared to buffered lidocaine alone and diphenhydramine with epinephrine, based on evaluations from both patients and physicians.

Diphenhydramine with epinephrine was significantly more painful to inject than buffered lidocaine or buffered lidocaine with epinephrine, indicating it may not be the best choice for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison trial of four injectable anesthetics for laceration repair. Ernst, AA., Marvez-Valls, E., Nick, TG., et al.[2019]

In a study of 52 adult patients with simple lacerations, benzyl alcohol (BA) was found to cause significantly less pain during infiltration compared to lidocaine (LID), with median pain scores of 7.5 mm for BA versus 19.5 mm for LID (p = 0.049).

Although more patients in the BA group required additional anesthesia (8 out of 26) compared to the LID group (2 out of 26), this difference was not statistically significant, suggesting that BA can be a suitable alternative for patients allergic to LID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benzyl alcohol with epinephrine as an alternative to lidocaine with epinephrine. Bartfield, JM., May-Wheeling, HE., Raccio-Robak, N., et al.[2019]

In a study involving 71 children with facial or scalp lacerations, the new topical anesthetic Mepivanor was found to be less effective than both TAC and 1% lidocaine infiltration for providing adequate anesthesia during laceration repair.

TAC, which contains a small amount of cocaine, was as effective as 1% lidocaine infiltration, suggesting that TAC can be used with reduced cocaine content, potentially lowering costs and minimizing the risk of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of topical anesthetics with lidocaine infiltration during laceration repair in children. Smith, GA., Strausbaugh, SD., Harbeck-Weber, C., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-lacerations-8-2023-d150d

Local Anesthesia for Vaginal Lacerations (PAIN Trial) Research shows that bupivacaine with epinephrine is effective in providing local anesthesia during laceration repairs, as it has a longer duration of action ...

2. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0d51133-882c-4f9e-ba1c-f037226305a1

MARCAINE WITH EPINEPHRINE- bupivacaine hydrochloride ... Use the lowest dosage of MARCAINE / MARCAINE WITH EPINEPHRINE that results in effective anesthesia to avoid high plasma levels and serious adverse effects.

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/018692s015lbl.pdf

Marcaine Bupivacaine Hydrochloride injection label The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000. Local anesthetics are bound to plasma proteins in varying degrees.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3496528/

PMC We randomized 27 women undergoing open gynecological surgery to receive either three XaraColl implants (each containing 50 mg bupivacaine hydrochloride) or ON-Q ...

5. fda.gov fda.gov/media/147234/download

Side-by-Side Product Comparison of Bupivacaine ... Bupivacaine is indicated in any type of peripheral anesthesia. • Local infiltration to nerve trunk, regional block. • Symphathetic nerve block.

6. mayoclinic.org mayoclinic.org/drugs-supplements/bupivacaine-and-epinephrine-injection-route/description/drg-20452206

Bupivacaine and epinephrine (injection route) Bupivacaine and epinephrine combination injection is used to numb an area of your body during surgery or other procedures, childbirth, or dental work.

7. pdr.net pdr.net/drug-summary/Marcaine-Marcaine-with-Epinephrine-bupivacaine-hydrochloride----bupivacaine-hydrochloride-epinephrine-1700

Marcaine - Drug Summary Bupivacaine's onset of action is rapid (2 to 10 minutes), and it is significantly longer lasting than other commonly used local anesthetics.