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Buffered vs Nonbuffered Lidocaine for Cervical Loop Excision
NCT01405768Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2011
- Primary completion
- Oct 2012
- Countries
- 1
- Sponsor
- Washington University School of Medicine
- Modality
- Small Molecules
- Conditions
- cervical dysplasia (CIN)
01
Overview
Phase 2, randomised trial of sodium bicarbonate and lidocaine in cervical dysplasia (CIN) (2 arms), sponsored by Washington University School of Medicine. Primary endpoint: Injection Pain Score at 30 minutes. Started Jul 2011; status: completed.
02
Design
2 arms- Study design
- Randomized
Lidocaine Arm
Non-buffered lidocaine with epinephrine
Buffered Lidocaine
Sodium bicarbonate buffered lidocaine with epinephrine
03
Who it enrols
Women aged 18 and older with cervical dysplasia (CIN 2/3, AIS, persistent CIN 1, etc.) undergoing LEEP, excluding those who are pregnant, have bleeding diathesis, or used analgesics within 7 days.
04
Endpoints
Primary
Injection Pain Score
Secondary
Overall LEEP Procedure Pain Including Procedural Pain and Cramping
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