Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
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ClinicalTrials.gov Identifier: NCT01405768 |
Recruitment Status
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Completed
First Posted
: July 29, 2011
Results First Posted
: July 28, 2014
Last Update Posted
: July 28, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | July 28, 2011 | |||
First Posted Date ICMJE | July 29, 2011 | |||
Results First Submitted Date | May 19, 2014 | |||
Results First Posted Date | July 28, 2014 | |||
Last Update Posted Date | July 28, 2014 | |||
Study Start Date ICMJE | July 2011 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Injection Pain Score [ Time Frame: immediately following 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.
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Change History | Complete list of historical versions of study NCT01405768 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Overall LEEP procedure pain (including procedural pain and cramping) [ Time Frame: immmediately following 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.
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs) | |||
Official Title ICMJE | 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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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Condition ICMJE | Uterine Cervical Dysplasia | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
56 | |||
Original Estimated Enrollment ICMJE |
54 | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01405768 | |||
Other Study ID Numbers ICMJE | 201104269 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Washington University School of Medicine | |||
Study Sponsor ICMJE | Washington University School of Medicine | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Washington University School of Medicine | |||
Verification Date | June 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |