Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

Completed · Phase 2

Conditions studied: Uterine Cervical Dysplasia

In brief

Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for their cervical block will experience less injection pain than women who receive plain lidocaine.

Key facts

Study ID

NCT01405768

Run by

Washington University School of Medicine

People needed

56

Starts

2011-07-01

Expected to finish

2012-12-01

Last updated by the study team

2014-07-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• antecedent biopsy read as
• cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer
• adenocarcinoma in situ
• persistent CIN 1
• antecedent pap read as
• high grade squamous intraepithelial lesion
• atypical glandular cells
• persistent low grade squamous intraepithelial lesion

You may not qualify if…

• anatomy unsuitable for safe office loop excision based on operator judgement
• inability to tolerate procedure under local anesthesia
• pregnancy
• age less than 18 years
• inability to understand spoken or written English
• refusal of consent
• prisoner
• mental incapacity
• anticoagulant or antiplatelet therapy, or known bleeding diathesis
• use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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