Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
Overall Participants Analyzed; [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
[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.
Indication [1]; [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
[1] 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
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) [1]; [Units: Participants]
10 x 10	5	11	16
15 x 12	2	0	2
10 x 8	1	0	1
[1] 8 patients in the Lidocaine arm had the endocervical loop used. 11 patients in the Buffered Lidocaine arm had the endocervical loop used.
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

  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 ]

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4. Secondary:

Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median) [ Time Frame: Within 30 minutes of completion of procedure ]

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  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:

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.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01405768 History of Changes
Other Study ID Numbers:	201104269
First Submitted:	July 28, 2011
First Posted:	July 29, 2011
Results First Submitted:	May 19, 2014
Results First Posted:	July 28, 2014
Last Update Posted:	July 28, 2014