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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: June 26, 2014
Last verified: June 2014
History of Changes
Results First Received: May 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Uterine Cervical Dysplasia
Interventions: Drug: sodium bicarbonate buffered lidocaine
Drug: Non-buffered lidocaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lidocaine Arm Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
Buffered Lidocaine

Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.

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.

Participant Flow:   Overall Study
    Lidocaine Arm     Buffered Lidocaine  
STARTED     28     28  
COMPLETED     24     28  
NOT COMPLETED     4     0  
Didn't complete questionnaire correctly                 4                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
4 women from the lidocaine arm who did not complete the questionnaire correctly were excluded from analysis

Reporting Groups
  Description
Lidocaine Arm Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
Buffered Lidocaine

Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.

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.
Total Total of all reporting groups

Baseline Measures
    Lidocaine Arm     Buffered Lidocaine     Total  
Number of Participants  
[units: participants]
 		  24     28     52  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     24     28     52  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  32.4  ± 10.3     32.3  ± 7.6     32.4  ± 9.2  
Gender  
[units: participants]
 		     
Female     24     28     52  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
 		     
African American     13     12     25  
White     10     14     24  
Hispanic/Latina     0     1     1  
Other     1     1     2  
Region of Enrollment  
[units: participants]
 		     
United States     24     28     52  
Parity [1]
[units: participants]
 		     
0     3     6     9  
1     5     7     12  
2+     16     15     31  
Indication [2]
[units: participants]
 		     
HSIL     8     4     12  
CIN 2     4     7     11  
CIN 3     11     15     26  
AIS     1     1     2  
Persistent CIN 1     0     1     1  
Procedure type  
[units: participants]
 		     
Ectocervix only     16     17     33  
Ectocervix and endocervix     8     11     19  
Number of passes  
[units: participants]
 		     
1     6     11     17  
2     12     12     24  
3+     6     5     11  
Ectocervical loop size (in mm)  
[units: participants]
 		     
15 x 12     3     7     10  
20 x 12     13     16     29  
Other     8     5     13  
Endocervical loop size (in mm) [3]
[units: participants]
 		     
10 x 10     5     11     16  
15 x 12     2     0     2  
10 x 8     1     0     1  
Estimated blood loss (in mL)  
[units: participants]
 		     
0 mL     3     6     9  
1-5 mL     9     8     17  
6-10 mL     7     9     16  
>10 mL     5     5     10  
Anesthetic volume (in mL)  
[units: participants]
 		     
6-9 mL     12     11     23  
10 mL     11     15     26  
>10 mL     1     2     3  
[1] Parity indicates the number of >20-week births (including viable and non-viable; i.e., stillbirths). Pregnancies consisting of multiples, such as twins or triplets, count as one birth for the purpose of this notation.
[2]

HSIL = High grade squamous intraepithelial lesion

CIN 2 = Cervical squamous intraepithelial neoplasia 2

CIN 3 = Cervical squamous intraepithelial neoplasia 2

AIS = Adenocarcinoma in situ

Persistent CIN 1 = Persistent cervical squamous intraepithelial neoplasia 1
[3]

8 patients in the Lidocaine arm had the endocervical loop used.

11 patients in the Buffered Lidocaine arm had the endocervical loop used.



  Outcome Measures
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1.  Primary:   Injection Pain Score (Mean)   [ Time Frame: Within 30 minutes of completion of procedure ]
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2.  Primary:   Injection Pain Score (Median)   [ Time Frame: Within 30 minutes of completion of the procedure ]
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3.  Secondary:   Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)   [ Time Frame: Within 30 minutes of completion of procedure ]
  Show Outcome Measure 3

4.  Secondary:   Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)   [ Time Frame: Within 30 minutes of completion of procedure ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • Small sample - may have missed a significant difference when one really exists
  • Procedures performed by 2nd year residents vs. procedure performed by more skilled surgeon (less pain)
  • Used needle extenders/27-gauge needles vs. Potocki needles


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: L. Stewart Massad, M.D.
Organization: Washington University School of Medicine
phone: 314-362-3181
e-mail: massadl@wudosis.wustl.edu


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
Results First Received: May 19, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board