Lidocaine Injections for Labor Pain

Overseen By Jeremy Reeves, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Opioids, IV magnesium sulfate

Disqualifiers: Cesarean delivery, Diabetes, BMI ≥ 35, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of using lidocaine, a numbing medication, to ease the pain of inserting an epidural needle during labor. It tests whether injecting lidocaine just under the skin (intradermally) or a bit deeper (subcutaneously) affects pain relief and overall satisfaction. Women currently in labor, planning to have an epidural, and not undergoing a cesarean delivery or having recently used opioids, may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance pain management techniques during labor.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have taken opioids in the last 4 hours or IV magnesium sulfate in the last 24 hours.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lidocaine is generally safe as a local pain reliever. Studies have found that using 1% lidocaine, whether injected just under the skin or into deeper tissue, does not significantly affect labor duration or increase the likelihood of assisted delivery, such as vacuum use or cesarean section. Using the correct dosage and method ensures safety.

Lidocaine is also considered one of the safest local pain relievers for pregnant women. However, like any medication, it can have side effects. For instance, an increase in the blood enzyme creatine phosphokinase may occur after muscle injections, though this is uncommon with the small doses used for labor pain relief.

Overall, lidocaine is well-tolerated, and serious reactions are rare when used correctly. Prospective trial participants should discuss any concerns with a healthcare provider before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about lidocaine injections for labor pain because they offer a potentially quicker and less invasive option for pain relief compared to traditional epidurals. Unlike epidurals, which require more extensive procedures and can take longer to administer, lidocaine can be injected intradermally or subcutaneously, providing rapid local anesthesia. This approach could reduce the need for more invasive interventions, enhancing comfort and convenience for laboring mothers. By exploring different delivery methods (intradermal vs. subcutaneous), this treatment aims to optimize pain management while possibly minimizing side effects and complications associated with deeper epidural injections.

What evidence suggests that lidocaine injections could be effective for labor pain?

This trial will compare two methods of administering lidocaine injections to reduce pain during labor. Research has shown that lidocaine injections effectively reduce labor pain. Participants in this trial will receive either an intradermal or subcutaneous injection of lidocaine before the epidural needle insertion. Studies indicate that using lidocaine in an epidural does not prolong labor or increase the likelihood of assisted delivery. For injections just under the skin, lidocaine provides effective pain relief during procedures and is usually well-tolerated. Both methods aim to lessen pain during epidural needle insertion, enhancing comfort. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women in labor who want epidural analgesia to manage pain. Participants must be eligible for the study based on their medical history reviewed before surgery. There are no specific inclusion or exclusion criteria provided.

Inclusion Criteria

I can understand and give consent in English.

Parturient women requesting epidural analgesia for laboring pain

Exclusion Criteria

BMI ≥ 35

Chronic pain patients

Opioid use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intradermal or subcutaneous lidocaine prior to epidural Tuohy needle insertion, with pain and physiological responses recorded

1 day

1 visit (in-person)

Follow-up

Participants' procedural satisfaction and physiological responses are assessed 30 minutes after the procedure

30 minutes

What Are the Treatments Tested in This Trial?

Interventions

• 1% Lidocaine Injection

Trial Overview The study compares two ways of giving lidocaine, a numbing medication, before inserting an epidural needle: one group gets it under the skin (subcutaneous), and another just below the surface of the skin (intradermal). Pain levels will be measured using two scales by someone who can't see which method was used.

How Is the Trial Designed?

Group I: INTRADERMAL Active Control 1 Intervention

Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal).

Group II: SUBCUTANEOUS Active Control 1 Intervention

Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine subcutaneously (Group Subcutaneous).

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 32 patients, 0.5% lidocaine was found to be a fast-onset and effective local anesthetic for initiating epidural analgesia in early labor, compared to traditional agents like bupivacaine.

The use of lidocaine for labor analgesia demonstrated safety and efficacy, suggesting it could be a preferable option for quicker pain relief during the early stages of labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low concentration lidocaine (0.5%) bolus epidurally can initiate fast-onset, effective and safe analgesia for early stage labor. Liu, H., Yao, S., Rosinia, F.[2014]

Over the past 20 years, there has been a significant increase in the variety of topical anesthetics available for preventing neonatal pain, moving beyond just lidocaine injections to include creams, gels, and heat-activated patches.

While lidocaine injections are still commonly used for painful procedures in newborns, this review highlights the need for practical information on newer topical anesthetic options to improve pain management in neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anesthesia in neonates: clinical practices and practical considerations. Lehr, VT., Taddio, A.[2007]

Viscous lidocaine can pose a high risk of overdose in pediatric patients due to their altered pharmacokinetics, making doses safe for adults potentially toxic for children.

Benzocaine is recommended as a safer alternative for treating painful mouth lesions in children, as it has a lower incidence of side effects, but if lidocaine must be used, clear and specific dosing instructions should be provided to parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? Gonzalez del Rey, J., Wason, S., Druckenbrod, RW.[2019]

Chloroprocaine provided a significantly faster onset of labor analgesia compared to lidocaine, with parturients receiving 1.5% chloroprocaine achieving adequate analgesia in an average of 7 minutes versus 12 minutes for those receiving lidocaine.

The study suggests that 6 mL of 1.5% chloroprocaine is the optimal regimen for labor analgesia, as it resulted in lower pain scores and higher maternal satisfaction without increasing adverse effects compared to both lidocaine and a lower concentration of chloroprocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial Comparing Different Concentrations of Chloroprocaine with Lidocaine for Activating Epidural Analgesia During Labor. Zhu, HJ., He, Y., Wang, SY., et al.[2022]

A case study highlighted a reproducible anaphylactic reaction to lidocaine hydrochloride, a common local anesthetic used in surgeries, emphasizing the need for caution in patients with potential allergies.

Early intervention with epinephrine, oxygen, and intravenous fluids effectively relieved the symptoms, underscoring the importance of prompt treatment in allergic reactions and the necessity of sensitivity testing before using lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylactic reaction to lidocaine. Kennedy, KS., Cave, RH.[2022]

In a study of 144 women, the use of lidocaine-prilocaine (LP) cream resulted in significantly lower pain scores during perineal repair compared to lidocaine infiltration, indicating it is a more effective analgesic option.

The LP cream not only reduced pain but also shortened the duration of the repair process and led to higher satisfaction rates among participants, with no significant differences in side effects between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical lidocaine-prilocaine cream versus lidocaine infiltration for pain relief during repair of perineal tears after vaginal delivery: randomized clinical trial. Abbas, AM., Abdel Hafiz, HA., Abdelhafez, AM., et al.[2019]

In a study involving 48 unmedicated laboring parturients, lidocaine 100 mg was found to be a highly sensitive marker for detecting intravascular injection, achieving a sensitivity of 100% when combined with symptoms of tinnitus and metallic taste.

The combination of tinnitus and metallic taste was identified as the most reliable indicator of intravenous injection, while the specificity for these symptoms was lower, indicating that while they are good indicators, they may not be definitive on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural test dose: lidocaine 100 mg, not chloroprocaine, is a symptomatic marker of i.v. injection in labouring parturients. Colonna-Romano, P., Lingaraju, N., Braitman, LE.[2018]

In a study involving 570 pregnant women undergoing amniocentesis, Xylocaine spray significantly reduced pain scores during the procedure compared to both a placebo and a control group, with median pain scores of 2.3, 3.3, and 2.8 respectively (p < 0.001).

Despite the reduction in pain during the procedure, the pain scores 30 minutes after the procedure were similar across all groups, suggesting that while Xylocaine is effective for immediate pain relief, the overall clinical significance may be limited due to the mild and short-lived nature of discomfort associated with amniocentesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Xylocaine spray for analgesia during amniocentesis: a randomized controlled trial. Homkrun, P., Tongsong, T., Srisupundit, K.[2020]

Lidocaine hydrochloride is the most commonly used anesthetic in dermatology, and adverse reactions are very rare, primarily consisting of vasovagal responses and local effects like bruising and swelling.

This report highlights an extremely rare case of a true type I hypersensitivity allergy to lidocaine, which is believed to account for only 1% of all adverse reactions to this anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case reports: type I hypersensitivity to lidocaine. Haugen, RN., Brown, CW.[2013]

The needle-free powder lidocaine delivery system provided significantly better pain relief compared to a sham placebo in pediatric patients undergoing venipuncture, as shown by lower pain scores on the Wong-Baker FACES scale (P = 0.0022).

The treatment was well tolerated with only minor side effects, such as erythema and petechiae, and no serious adverse events were reported, indicating it is a safe option for providing analgesia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial. Schmitz, ML., Zempsky, WT., Meyer, JM.[2018]

In a study of 23 samples of a lidocaine and phenylephrine topical solution, only 3 samples showed bacterial contamination, indicating a low risk of infection when using a modified application technique.

The modified technique, which involves keeping the spray nozzle pressed while withdrawing it from the patient, suggests that this topical solution could be safely used as a multi-use spray, potentially reducing costs without increasing infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-use lidocaine hydrochloride 5 per cent w/v and phenylephrine hydrochloride 0.5 per cent w/v topical spray; can it now be employed as a multi-use atomiser? Jog, M., Zudovaite, I., O'Dwyer, M., et al.[2020]

In a study involving 81 women in labor, bupivacaine was found to be significantly more potent than lidocaine, with a minimum local analgesic concentration (MLAC) of 0.065% for bupivacaine compared to 0.37% for lidocaine, indicating that bupivacaine is 5.7 times more effective in providing pain relief.

The study established a clinical model to determine effective concentrations of local anesthetics, which can help in assessing the analgesic potency of other epidural analgesics in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the minimum local analgesic concentrations of epidural bupivacaine and lidocaine in labor. Columb, MO., Lyons, G.[2022]

In a study of 57 first-time mothers, those who delivered vaginally required significantly lower concentrations of bupivacaine for epidural analgesia compared to those who underwent cesarean sections, suggesting that higher local anesthetic needs may indicate more intense pain due to dystocia.

The findings imply that women experiencing dystocia during labor require more local anesthetic, which could influence the relationship between epidural analgesia and labor progression, highlighting the importance of pain management strategies in labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local anesthetic requirements are greater in dystocia than in normal labor. Panni, MK., Segal, S.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1764008/

Effects of epidural lidocaine analgesia on labor and delivery Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery ...

2. withpower.com withpower.com/trial/lidocaine-injections-for-labor-pain-262d2

Lidocaine Injections for Labor Pain Research shows that a lower concentration of lidocaine (0.5%) can quickly and effectively provide pain relief when used as an epidural during early labor. This ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6050998/

Comparison of Efficacy Outcomes of Lidocaine Spray, Topical ... At 6 hours after surgery, patients in the general lidocaine (GL) group reported decreased postoperative pain compared with those in the topical lidocaine (TL) ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/006488s095_s090lbl.pdf

Xylocaine-MPF (Epinephrine and Lidocaine Hydrochloride) How- ever, spinal and epidural anesthesia have also been reported to prolong the second stage of labor by removing the parturient's reflex urge to bear down or ...

5. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-024-06640-7

Lidocaine spray vs mepivacaine local infiltration for suturing ... Our study demonstrates that lidocaine spray alone can be used as a first line of local anesthetic during the closure of I-II-grade perineal lacerations.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/006488s074lbl.pdf

Xylocaine (lidocaine HCl Injection, USP) - accessdata.fda.gov The safety and effectiveness of lidocaine HCl ... The intramuscular injection of lidocaine HCl may result in an increase in creatine phosphokinase levels.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10315135/

Physiology of pregnancy and oral local anesthesia ... Lidocaine and prilocaine are rated B by the FDA and are considered the safest local anesthetic for pregnant women. Because the concentration of ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/006488s097lbl.pdf

(lidocaine HCl Injection, USP) Xylocaine The safety and effectiveness of lidocaine HCl depend on proper ... The intramuscular injection of lidocaine HCl may result in an increase in creatine.