Clinical trial NCT03444727: Treatment Prior to Injection and Biopsy of the Vulva
Official title: Treatment Prior to Injection and Biopsy of the Vulva
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulvar Diseases
Anesthesia
Anesthesia, Local
Keywords: vulvar biopsy
ice
anesthesia
pain
vulva
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either pre-treatment with ice inside a sterile glove or with room-temperature water inside an exam glove.
Primary purpose: TREATMENT

Brief summary: This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.

Detailed description: To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area.

Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues.

The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.

Eligibility criteria: Inclusion Criteria:

* Female
* 18 years of age or older
* Undergoing vulva biopsy during clinic visit
* Willing and able to comply with study protocol
* Able to understand and provide informed consent

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Post-injection Pain Score
timeFrame: Immediately after local anesthetic injection
Secondary outcomes:
measure: Post-procedure satisfaction score
timeFrame: Immediately after procedure
measure: Post-procedure anxiety score
timeFrame: Immediately after procedure
measure: Post-procedure pain control score
timeFrame: Immediately after procedure
measure: Post-biopsy pain score
timeFrame: Immediately after procedure.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Ob/Gyn Associated
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Courtney Barnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuwahara RT, Skinner RB. Emla versus ice as a topical anesthetic. Dermatol Surg. 2001 May;27(5):495-6. doi: 10.1046/j.1524-4725.2001.00343.x.
citation: Chan HH, Lam LK, Wong DS, Wei WI. Role of skin cooling in improving patient tolerability of Q-switched Alexandrite (QS Alex) laser in nevus of Ota treatment. Lasers Surg Med. 2003;32(2):148-51. doi: 10.1002/lsm.10112.
citation: Goel S, Chang B, Bhan K, El-Hindy N, Kolli S. "Cryoanalgesic preparation" before local anaesthetic injection for lid surgery. Orbit. 2006 Jun;25(2):107-10. doi: 10.1080/01676830600675392.
citation: Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x.
citation: Dixit S, Lowe P, Fischer G, Lim A. Ice anaesthesia in procedural dermatology. Australas J Dermatol. 2013 Nov;54(4):273-6. doi: 10.1111/ajd.12057. Epub 2013 Apr 26.
citation: Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized clinical trial". Dent Res J (Isfahan). 2013 Nov;10(6):790-4.
citation: Lindsell LB, Miller DM, Brown JL. Use of topical ice for local anesthesia for intravitreal injections. JAMA Ophthalmol. 2014 Aug;132(8):1010-1. doi: 10.1001/jamaophthalmol.2014.1397. No abstract available.
citation: Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
citation: Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.
citation: Bhadauria US, Dasar PL, Sandesh N, Mishra P, Godha S. Effect of injection site pre-cooling on pain perception in patients attending a dental camp at Life Line Express: a split mouth interventional study. Clujul Med. 2017;90(2):220-225. doi: 10.15386/cjmed-694. Epub 2017 Apr 25.