Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

Tracking Information
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; (submitted: June 26, 2014)	Injection Pain Score (Mean) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures ICMJE; (submitted: July 28, 2011)	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.
Change History	Complete list of historical versions of study NCT01405768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 26, 2014)	Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean) [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE; (submitted: July 28, 2011)	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.
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: 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.); 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 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
Condition ICMJE	Uterine Cervical Dysplasia
Intervention ICMJE	Drug: sodium bicarbonate buffered lidocaine 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.; Drug: Non-buffered lidocaine
Study Arms	Active Comparator: Lidocaine Arm Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure. Intervention: Drug: Non-buffered lidocaine; Experimental: Buffered Lidocaine Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure. Intervention: Drug: sodium bicarbonate buffered lidocaine
Publications *	Ruegg TA, Curran CR, Lamb T. Use of buffered lidocaine in bone marrow biopsies: a randomized, controlled trial. Oncol Nurs Forum. 2009 Jan;36(1):52-60. doi: 10.1188/09.ONF.52-60.; Sharma T, Gopal L, Shanmugam MP, Bhende P, George J, Samanta TK, Mukesh BN. Comparison of pH-adjusted bupivacaine with a mixture of non-pH-adjusted bupivacaine and lignocaine in primary vitreoretinal surgery. Retina. 2002 Apr;22(2):202-7.; Fitton AR, Ragbir M, Milling MA. The use of pH adjusted lignocaine in controlling operative pain in the day surgery unit: a prospective, randomised trial. Br J Plast Surg. 1996 Sep;49(6):404-8.; Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31.; Younis I, Bhutiani RP. Taking the 'ouch' out - effect of buffering commercial xylocaine on infiltration and procedure pain - a prospective, randomised, double-blind, controlled trial. Ann R Coll Surg Engl. 2004 May;86(3):213-7.; Masters JE. Randomised control trial of pH buffered lignocaine with adrenaline in outpatient operations. Br J Plast Surg. 1998 Jul;51(5):385-7.; Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 26, 2014)	56
Original Estimated Enrollment ICMJE; (submitted: July 28, 2011)	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: 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
Sex/Gender	Sexes Eligible for Study: Female
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	Principal Investigator: L. Stewart Massad, M.D. Washington University School of Medicine
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