Status:
COMPLETED
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Lead Sponsor:
Washington University School of Medicine
Conditions:
Uterine Cervical Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Specific aims: 1. To determine whether buffering the agent used for intracervical anesthetic at the time of cervical loop excision reduces injection-related pain. (Hypothesis: buffering significantly...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01405768
Start Date
July 1 2011
End Date
December 1 2012
Last Update
July 28 2014
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110