Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01405768
First received: July 28, 2011
Last updated: July 12, 2013
Last verified: July 2013
  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 2

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

Resource links provided by NLM:


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: 55
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.

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Leslie S Massad, M.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
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: July 12, 2013
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 July 22, 2014