Lidocaine-Prilocaine Cream Compared With Injected Lidocaine for Vulvar Biopsy: A Randomized Controlled Trial.
Aged
Anesthetics, Local
/ therapeutic use
Biopsy, Needle
/ methods
Female
Humans
Injections
Lidocaine
/ therapeutic use
Lidocaine, Prilocaine Drug Combination
/ therapeutic use
Linear Models
Middle Aged
Nerve Block
/ methods
Ointments
Pain
/ prevention & control
Pain Management
Pain Measurement
Patient Satisfaction
Perineum
Vulva
/ pathology
Journal
Obstetrics and gynecology
ISSN: 1873-233X
Titre abrégé: Obstet Gynecol
Pays: United States
ID NLM: 0401101
Informations de publication
Date de publication:
02 2020
02 2020
Historique:
pubmed:
11
1
2020
medline:
24
6
2020
entrez:
11
1
2020
Statut:
ppublish
Résumé
To compare pain control during vulvar biopsy after either application of 5% lidocaine-prilocaine cream or injection of 1% lidocaine. In a single-site randomized trial, patients who needed vulvar biopsy on a non-hair-bearing surface were recruited from a gynecologic oncology clinic to compare lidocaine-prilocaine cream (placed at least 10 minutes before biopsy) with lidocaine injection (at least 1 minute prior). A sample size of 53 participants in each arm (N=106) was planned. Pain was recorded using a 100 mm visual analog scale at three time points: baseline, after application of anesthesia, and after biopsy. The primary outcome was highest pain score recorded. Secondary outcomes were pain score at biopsy, patient experience, and tolerability and acceptability. Linear regression was used to compare the primary outcome between arms while controlling for baseline vulvar pain. A convenience analysis was performed in March 2019. From October 2018 to March 2019, 38 patients completed informed consent and were randomized. Participants were women with median age of 60 years. Most characteristics between groups were similar. Nineteen were analyzed in the lidocaine-prilocaine group, and 18 were analyzed in the lidocaine injection group. The median highest pain score in the lidocaine-prilocaine group was 20.0 mm vs 56.5 mm in the lidocaine injection group. Controlling for baseline pain, the highest pain score in the lidocaine-prilocaine arm was 25.7 mm lower than in the lidocaine injection arm (95% CI [-45.1 to -6.3]; P<.01). Patients randomized to lidocaine-prilocaine had a significantly better experience than those receiving injected lidocaine (median experience score 2.0 mm vs 17.0 mm; P=.02). Lidocaine-prilocaine cream before vulvar biopsy resulted in a lower maximum pain score and a significantly better patient rating of the biopsy experience when compared with lidocaine injection. Lidocaine-prilocaine cream, alone, is a reasonable option to use for vulvar biopsy. ClinicalTrials.gov, NCT03654417.
Identifiants
pubmed: 31923074
doi: 10.1097/AOG.0000000000003660
pii: 00006250-202002000-00010
doi:
Substances chimiques
Anesthetics, Local
0
Lidocaine, Prilocaine Drug Combination
0
Ointments
0
Lidocaine
98PI200987
Banques de données
ClinicalTrials.gov
['NCT03654417']
Types de publication
Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
311-318Références
Mcilwaine K, Readman E, Cameron M, Maher P. Outpatient hysteroscopy: factors influencing post-procedure acceptability in patients attending a tertiary referral centre. Aust N Zealand J Obstet Gynaecol 2009;49:650–2.
Diagnosis and management of vulvar skin disorders. ACOG Practice Bulletin No. 93. American College of Obstetricians and Gynecologists. Obstet Gynecol 2008;111:1243–53.
Schober J, Cooney T, Pfaff D, Mayoglou L, Martin-Alguacil N. Innervation of the labia minora of prepubertal girls. J Pediatr Adolesc Gynecol 2010;23:352–7.
Ireland LD, Allen RH. Pain management for gynecologic procedures in the office. Obstet Gynecol Surv 2016;71:89–98.
Bettocchi S, Ceci O, Nappi L, Di Venere R, Masciopinto V, Pansini V, et al. Operative office hysteroscopy without anesthesia: analysis of 4863 cases performed with mechanical instruments. J Am Assoc Gynecol Laparosc 2004;11:59–61.
Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract 1995;41:169–75.
McLenon J, Rogers MAM. The fear of needles: a systematic review and meta-analysis. J Adv Nurs 2019;75:30–42.
Allen RH, Micks E, Edelman A. Pain relief for obstetric and gynecologic ambulatory procedures. Obstet Gynecol Clin North Am 2013;40:625–45.
Zilbert A. Topical anesthesia for minor gynecological procedures: a review. Obstet Gynecol Surv 2002;57:171–8.
vd Berg GM, Lillieborg S, Stolz E. Lidocaine/prilocaine cream (EMLAI) versus infiltration anaesthesia: a comparison of the analgesic efficacy for punch biopsy and electrocoagulation of genital warts in men. Genitourin Med 1992;68:162–5.
Drouault Y, Guillet G, Morel P, Vilmer C, Benes G, Trinquet F. Comparison of the analgesic efficacy of EMLA 5% cream and lidocaine infiltration for biopsy of the genital mucosa [in French]. Ann Dermatol Venereol 1997;124:448–51.
van der Burght M, Schonemann NK, Laursen JK, Arendt-Nielsen L, Bjerring P. Duration of analgesia following application of eutectic mixture of local anaesthetics (EMLA) on genital mucosa. Acta Derm Venereol 1993;73:456–8.
EMLA. FDA access database 2006. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/19941s11lbl.pdf. Retrieved April 2, 2017.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDC—)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81.
Lowe B, Decker O, Muller S, Brähler E, Schellberg D, Herzog W, et al. Validation and standardization of the generalized anxiety disorder screener (GAD-7) in the general population. Med Care 2008;46:266–74.
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain 1986;27:117–26.
Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med 1996;27:485–9.
Paul-Dauphin A, Guillemin F, Virion JM, Briancon S. Bias and precision in visual analogue scales: a randomized controlled trial. Am J Epidemiol 1999;150:1117–27.
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med 2001;8:1153–7.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res 2011;63(suppl 11):S240–52.
Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med 2001;38:633–8.
Cazes A, Prost-Squarcioni C, Bodemer C, Heller M, Brousse N, Fraitag S. Histologic cutaneous modifications after the use of EMLA cream, a diagnostic pitfall: review of 13 cases. JAMA Dermatol 2007;143:1073–87.
Lewis FM, Agarwal A, Neill SM, Calonje JE, Stefanato CM. The spectrum of histopathologic patterns secondary to the topical application of EI(R) on vulvar epithelium: clinicopathological correlation in three cases. J Cutan Pathol 2013;40:708–13.