Phase 2
Completed N=56
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Uterine Cervical Dysplasia
Source: ClinicalTrials.gov NCT01405768 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Injection Pain Score (Mean) — 25; 19 units on a scale — p=.13
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.
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 | — |
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
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. Informational only — not medical advice.