Phase 2 N=56 Randomized Triple-blind Supportive Care

Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

Uterine Cervical Dysplasia

Bottom Line

View on ClinicalTrials.gov: NCT01405768 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Injection Pain Score (Mean) — 25; 19 units on a scale — p=.13

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sodium bicarbonate buffered lidocaine (Drug); Non-buffered lidocaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Washington University School of Medicine
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Injection Pain Score (Mean)	25; 19	.13
PRIMARY Injection Pain Score (Median)	26; 18	.13
SECONDARY Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)	25; 19; 27; 19; 19; 18	—
SECONDARY Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)	26; 18; 25; 13; 19; 14	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.