Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

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 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

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