Brief Title
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Official Title
A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision
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 reduces injection-related pain.) 2. To determine whether other components of pain from LEEP (procedural pain, and cramping) can be reduced by buffering of intracervical anesthetic among women undergoing cervical loop excision. (Hypothesis: only injection pain will be reduced by buffering, as procedural pain will be reduced by lidocaine equally in both arms and cramping will not be reduced in either arm.) Background: Although cervical cancer rates have been dramatically reduced by Pap test screening and the eradication of precursors, more than 100,000 U.S. women develop premalignant cervical lesions each year that require treatment (1). The cervical loop electrosurgical excision procedure (LEEP) is the most common therapy for CIN among U.S. gynecologists. LEEP is performed using one or more 1-2 cm electrosurgical diathermy loops to excise involved and at-risk cervical epithelium including underlying stroma containing glands. Destroying this tissue eliminates cells infected with human papillomavirus, the proximate cause of cervical cancer, and radically reduces the risk of later developing cervical cancer (2, 3). LEEP is usually performed as an outpatient procedure using intracervical anesthesia, most commonly combining lidocaine as an anesthetic agent with epinephrine as a hemostatic agent; final hemostasis is achieved using electrosurgical fulguration and topical hemostatic agents (4). Prior literature has suggested that pain from LEEP has 3 components: pain from injection of the anesthetic combination, pain from the excision, and cramping from reflex uterine contractions (5). While cramping can be controlled with oral nonsteroidal anti-inflammatory agents, injection and procedural pain are not. Most women categorize the pain of LEEP as 3-7 on a 0-10 Likert scale (5, 6). Studies of dermal and ocular anesthesia and bone marrow biopsy have found that buffering of acidic local anesthetic agents reduces injection pain (7-14), with up to 66% reduction in pain and significant results in randomized trials involving 30-50 participants. However, the use of buffered lidocaine has not yet been tested for LEEPs. The principal investigator has used both forms of anesthesia and considers both acceptable forms of therapy; he is unaware of any evidence to support the superiority of either arm.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Injection Pain Score (Mean)
Secondary Outcome
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)
Condition
Uterine Cervical Dysplasia
Intervention
sodium bicarbonate buffered lidocaine
Study Arms / Comparison Groups
Lidocaine Arm
Description: Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
56
Start Date
July 2011
Completion Date
December 2012
Primary Completion Date
October 2012
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
L. Stewart Massad, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01405768
Organization ID
201104269
Responsible Party
Sponsor
Study Sponsor
Washington University School of Medicine
Study Sponsor
L. Stewart Massad, M.D., Principal Investigator, Washington University School of Medicine
Verification Date
June 2014