Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Uterine Cervical Dysplasia	Drug: sodium bicarbonate buffered lidocaine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Lidocaine Sodium bicarbonate Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Injection Pain Score [ Time Frame: Immediately following procedure ] [ Designated as safety issue: No ]
A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.

Secondary Outcome Measures:

Overall LEEP procedure pain (including procedural pain and cramping) [ Time Frame: immmediately following procedure ] [ Designated as safety issue: No ]
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.

Enrollment:	58
Study Start Date:	July 2011
Study Completion Date:	December 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Lidocaine Arm Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
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.	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.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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, and 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 within 7 days of scheduled LEEP

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405768

Locations

United States, Missouri
Barnes-Jewish Hosptial/Siteman Cancer Center
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Leslie S Massad, MD

Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

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.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01405768 History of Changes
Other Study ID Numbers:	201104269
Study First Received:	July 28, 2011
Last Updated:	December 20, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Epinephrine
Epinephryl borate
Lidocaine
Adrenergic beta-Agonists

Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics

ClinicalTrials.gov processed this record on May 23, 2013