Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

Phase 2

Completed

• Conditions: Uterine Cervical Dysplasia
• Interventions: Drug: Non-buffered lidocaine; Drug: sodium bicarbonate buffered lidocaine

• Registration Number: NCT01405768
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Results First Submitted: 2014-05-19
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Arm	Non-buffered lidocaine	Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
Buffered Lidocaine	sodium bicarbonate buffered lidocaine	Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.

Primary Outcome Measures

Name	Time	Method
Injection Pain Score (Mean)	Within 30 minutes of completion of procedure	A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.; Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.; Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.
Injection Pain Score (Median)	Within 30 minutes of completion of the procedure	A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.; Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.; Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.

Secondary Outcome Measures

Name	Time	Method
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)	Within 30 minutes of completion of procedure	A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.; Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.; Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)	Within 30 minutes of completion of procedure	A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.; Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.; Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States