Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
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.
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.
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