Local Anesthesia for Vaginal Lacerations
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Montefiore Medical Center
Must be taking: Epidural analgesia
Disqualifiers: Operative delivery, Multiple gestation, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications.
The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction.
This is a superiority two-arm, quadruple-blinded, prospective randomized controlled trial with the objective to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair. Women with a working epidural analgesia, and status post a vaginal delivery involving a second-degree laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get an injection with saline. The differences in perineal pain between the groups will be evaluated at time of the first analgesic (TFA) demand, maternal satisfaction at 24 hours, and visual analog scale (VAS) pain score.
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 data supports the effectiveness of the drug Bupivacaine with Epinephrine for treating vaginal lacerations?
Research shows that bupivacaine with epinephrine is effective in providing local anesthesia during laceration repairs, as it has a longer duration of action and a favorable balance between potency and safety compared to other anesthetics.
12345Is Bupivacaine with Epinephrine safe for use in humans?
Bupivacaine with Epinephrine is generally considered safe for use in humans, with studies showing minimal side effects when used in obstetrics and facial plastic surgery, provided that recommended doses are followed.
16789What makes the drug Bupivacaine with Epinephrine unique for treating vaginal lacerations?
Bupivacaine with Epinephrine is unique because it combines a long-lasting local anesthetic (Bupivacaine) with a vasoconstrictor (Epinephrine) that helps reduce bleeding and prolongs the anesthetic effect, which may be particularly beneficial for managing pain and bleeding during vaginal laceration repair.
3581011Eligibility Criteria
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
I speak English or Spanish.
My epidural is working during my laceration repair.
I am 18 years old or older.
+2 more
Exclusion Criteria
Allergic to bupivacaine and/or epinephrine
I received a combined spinal-epidural anesthesia.
Multiple gestation
+4 more
Trial Timeline
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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Local Anesthesia armExperimental Treatment2 Interventions
Bupivicaine and Epinephrine
Group II: Normal saline sham armPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical CenterBronx, NY
Loading ...
Who Is Running the Clinical Trial?
Montefiore Medical CenterLead Sponsor
References
Bupivacaine: a review. [2018]A review of current significant literature concerning bupivacaine hydrochloride (Marcaine) is presented with particular emphasis on clinical use in oral surgery. The major advantages compared with other presently used local anesthetics are an increased duration of action and a favorable potency to toxicity ratio.
Prilocaine-phenylephrine and bupivacaine-phenylephrine topical anesthetics compared with tetracaine-adrenaline-cocaine during repair of lacerations. [2019]The effectiveness of two new topical anesthetics that do not contain cocaine (prilocaine-phenylephrine and bupivacaine-phenylephrine) was compared with that of tetracaine-adrenaline-cocaine (TAC) during laceration repair in children. This study was a prospective, randomized, double-blind trial conducted in the emergency department of a large children's hospital. Participants were 180 children 1 year of age or older with a laceration 5 cm or less in length that required suturing. Pain felt during suturing was scored by suture technicians, research assistants, parents, and patients 5 years of age and older using a visual analogue scale (VAS). There was no statistical difference demonstrated between the effectiveness of prilocaine-phenylephrine and that of TAC for any of the observer groups. A statistically significant difference was seen among anesthetics when comparing VAS scores of research assistants (P = .002), suture technicians (P = .006), and parents (P = .03), but not when comparing VAS ratings of patients (P = .07). Based on Tukey's post hoc test, these statistically significant differences were between TAC and bupivacaine-phenylephrine. When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 1.3 VAS units for each rater group. In conclusion, this study demonstrated the effectiveness and safety of prilocaine-phenylephrine and bupivacaine-phenylephrine. Prilocaine-phenylephrine statistically outperformed bupivacaine-phenylephrine and offers an effective alternative to TAC during laceration repair in children.
Comparison of topical anesthetics with lidocaine infiltration during laceration repair in children. [2017]This study is a randomized, blinded trial that compares the effectiveness of a new topical anesthetic preparation of 2% mepivacaine and 1:100,000 norepinephrine (Mepivanor); a topical solution of 1% tetracaine, 1:4,000 adrenaline, and 4% cocaine (TAC); and 1% lidocaine infiltration during laceration repair in children. The study was conducted in the emergency department of a large academic children's hospital. Study participants were children 2 years of age or older with a laceration on the face or scalp, 5 cm or less in length, that required suturing. Patients were randomly assigned to receive Mepivanor topical solution, TAC topical solution, or lidocaine infiltration anesthesia prior to laceration repair. Seventy-one patients were enrolled in the study during a 2-month period. Outcome measures assessed pain perceptions using a Visual Analogue Scale (VAS) and a seven-point Likert scale. There was statistical power to detect differences of 1.2 to 1.7 units for the VAS outcome measures using alpha = 0.05 and beta = 0.20. There were no statistically significant (P > 0.05) differences between TAC and 1% lidocaine infiltration in providing effective anesthesia. Mepivanor was generally less effective in providing adequate anesthesia during laceration repair than TAC and lidocaine infiltration, with Tukey's post hoc test for ANOVA demonstrating statistically significant (P
Benzyl alcohol with epinephrine as an alternative to lidocaine with epinephrine. [2019]A randomized, prospective, double-blind study comparing benzyl alcohol with epinephrine, 1:100,000 (BA), and lidocaine with epinephrine, 1:100,000 (LID), as local anesthetics was carried out on adult patients with simple lacerations. The two study groups were compared for pain of infiltration (100 mm visual analog scale) and need for additional anesthesia. Pain scores were compared by a Mann Whitney Independent Rank Sum test and need for additional anesthesia by a Fishers Exact test. A total of 52 subjects (26 per group) were analyzed. The groups were similar in demographics and wound characteristics. The median pain score for BA, 7.5 mm, was less than for LID, 19.5 mm (p = 0.049). Although more patients receiving BA required additional anesthesia as compared to LID (8/26 versus 2/26), this difference did not reach statistical significance. BA is a reasonable alternative local anesthetic to LID for patients who are allergic to LID.
Tetracaine-lidocaine-phenylephrine topical anesthesia compared with lidocaine infiltration during repair of mucous membrane lacerations in children. [2017]This study compared the effectiveness of a new topical anesthetic, tetracaine-lidocaine-phenylephrine (TetraLidoPhen), with that of lidocaine infiltration during repair of mucous membrane lacerations in children. It was conducted in the emergency department of an urban children's hospital with use of a prospective, randomized, blinded study design. Participants were 90 children 1 year of age or older with a laceration 5 cm or less in length on or near a mucous membrane that required suturing. They were randomly assigned to one of two treatment groups, with 45 patients in each group. Pain felt during suturing was scored by suture technicians, research assistants, a videotape reviewer, parents, and patients 5 years of age and older using a Visual Analogue Scale (VAS). Suture technicians, research assistants, a videotape reviewer, and parents also scored pain using a seven-point Likert scale. In addition, suture technicians completed an Anesthesia Effectiveness scale and a Wound Blanching scale. The laceration was located near the eyes in 71 patients (79%), and on or near the lips in 19 (21%). Lidocaine infiltration performed significantly better than topical TetraLidoPhen in comparisons of Likert scores of suture technicians (P = 0.007), research assistants (P = 0.005), the videotape reviewer (P = 0.003), and parents (P = 0.03); Anesthetic Effectiveness scale scores of suture technicians (P = 0.00002; relative risk (RR) = 1.83, 95% confidence interval 1.36
Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. [2022]The ideal local anesthetic agent for facial plastic surgery should have rapid onset, good surgical anesthesia, and reasonably long duration. The purpose of this prospective, randomized, double-blind study was to compare 1% lidocaine hydrochloride with 1:200,000 epinephrine with 0.5% bupivacaine hydrochloride with 1:200,000 epinephrine, a newer, longer-acting local anesthetic, in different facial operations. The results suggest that bupivacaine is an effective and safe agent for these procedures.
[The use of Marcaine in obstetrical analgesia]. [2013]Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.
Comparison trial of four injectable anesthetics for laceration repair. [2019]To compare four injectable anesthetics (buffered 1% lidocaine, buffered 1% lidocaine with epinephrine, plain 1% lidocaine with epinephrine, and 0.5% diphenhydramine with epinephrine) for pain of infiltration and effectiveness of anesthesia during suturing of minor lacerations.
[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]Two forms of 0.5% bupivacaine hydrochloride, Anecaine (Pliva) (n = 15) and Marcaine (Astra) (n = 15) were used for epidural anesthesia. The clinical picture of conduction block induced by the two local anesthetics varied. It manifested by a shorter latent period of analgesia development at the level of catheter and the drug infusion (LII) and relatively delayed development of analgesia in peripheral zones for Anecaine in comparison with marcaine. The authors conclude that solutions of local anesthetics containing the same active agent in the same concentrations under different commercial names manufactured by different companies may be characterized by different clinical picture of conduction blockade.
Prilocaine versus plain or buffered lidocaine for local anesthesia in laceration repair: randomized double-blind comparison. [2013]To compare the effectiveness of 2% prilocaine plain solution, 1% lidocaine hydrochloride, and 1% buffered lidocaine in local anesthesia and pain reduction during injection in laceration repair.
Triple Versus Single Application of Lidocaine, Epinephrine, and Tetracaine for Laceration Repair in Children. [2023]Lidocaine (4%), epinephrine (0.1%), and tetracaine (0.5%) topical gel (LET) is a safe and effective method of providing anesthesia for laceration repair. Some patients, however, require additional infiltrated local anesthetic. We sought to determine if 3 applications of LET 10 minutes apart (triple LET) result in lower pain scores with suturing than one application for 30 minutes (single LET).