Treatment Prior to Injection and Biopsy of the Vulva

NCT03444727 | Terminated

• 1 other identifier: 2010101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Diseases; Anesthesia; Anesthesia, Local

Keywords

vulvar biopsy; ice; anesthesia; pain; vulva

Outcome Measures

Primary Outcomes (1)

• Post-injection Pain Score

  Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain.

  Immediately after local anesthetic injection

Secondary Outcomes (4)

• Post-procedure satisfaction score

  Immediately after procedure

• Post-procedure anxiety score

  Immediately after procedure

• Post-procedure pain control score

  Immediately after procedure

• Post-biopsy pain score

  Immediately after procedure.

Study Arms (2)

Ice Pre-treatment

EXPERIMENTAL

Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.

Other: Ice Pre-treatment

Room Temperature Water Pre-Treatment

PLACEBO COMPARATOR

Participants will hold an exam glove filled with room temperature water to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.

Other: Room Temperature Water Pre-treatment

Interventions

Ice Pre-treatment OTHER

Topical application of ice prior to local anesthetic injection.

Ice Pre-treatment

Room Temperature Water Pre-treatment OTHER

Topical application of room-temperature water prior to local anesthetic injection.

Room Temperature Water Pre-Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Ob/Gyn Associated

Columbia, Missouri, 65202, United States

Location

Related Publications (10)

• 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.

  PMID: 11359502 BACKGROUND

• 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.

  PMID: 12561049 BACKGROUND

• 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.

  PMID: 16754218 BACKGROUND

• 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.

  PMID: 17567343 BACKGROUND

• 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.

  PMID: 23617804 BACKGROUND

• 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.

  PMID: 24379869 BACKGROUND

• 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.

  PMID: 24945871 BACKGROUND

• 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.

  PMID: 26379379 BACKGROUND

• 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.

  PMID: 26957683 BACKGROUND

• 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.

  PMID: 28559708 BACKGROUND

MeSH Terms

Conditions

Vulvar Diseases; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney Barnes, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: Participants will be randomly assigned to either pre-treatment with ice inside a sterile glove or with room-temperature water inside an exam glove.

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 23, 2018
• Study Start: February 19, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)