Trial Outcomes & Findings for Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs) (NCT NCT01405768)
NCT ID: NCT01405768
Last Updated: 2014-07-28
Results Overview
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.
COMPLETED
PHASE2
56 participants
Within 30 minutes of completion of procedure
2014-07-28
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Didn't complete questionnaire correctly
|
4
|
0
|
Baseline Characteristics
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Baseline characteristics by cohort
| Measure |
Lidocaine Arm
n=24 Participants
Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
|
Buffered Lidocaine
n=28 Participants
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
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
32.3 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
32.4 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
10 participants
n=99 Participants
|
14 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
28 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Parity
0
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Parity
1
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Parity
2+
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
Indication
HSIL
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Indication
CIN 2
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Indication
CIN 3
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Indication
AIS
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Indication
Persistent CIN 1
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Procedure type
Ectocervix only
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Procedure type
Ectocervix and endocervix
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Number of passes
1
|
6 participants
n=99 Participants
|
11 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Number of passes
2
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Number of passes
3+
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Ectocervical loop size (in mm)
15 x 12
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Ectocervical loop size (in mm)
20 x 12
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Ectocervical loop size (in mm)
Other
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Endocervical loop size (in mm)
10 x 10
|
5 participants
n=99 Participants
|
11 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Endocervical loop size (in mm)
15 x 12
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Endocervical loop size (in mm)
10 x 8
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Estimated blood loss (in mL)
0 mL
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Estimated blood loss (in mL)
1-5 mL
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Estimated blood loss (in mL)
6-10 mL
|
7 participants
n=99 Participants
|
9 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Estimated blood loss (in mL)
>10 mL
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Anesthetic volume (in mL)
6-9 mL
|
12 participants
n=99 Participants
|
11 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Anesthetic volume (in mL)
10 mL
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Anesthetic volume (in mL)
>10 mL
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes of completion of procedureA 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.
Outcome measures
| Measure |
Lidocaine Arm
n=24 Participants
Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
|
Buffered Lidocaine
n=28 Participants
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.
|
|---|---|---|
|
Injection Pain Score (Mean)
|
25 units on a scale
Standard Deviation 19
|
19 units on a scale
Standard Deviation 17
|
PRIMARY outcome
Timeframe: Within 30 minutes of completion of the procedureA 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.
Outcome measures
| Measure |
Lidocaine Arm
n=24 Participants
Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
|
Buffered Lidocaine
n=28 Participants
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.
|
|---|---|---|
|
Injection Pain Score (Median)
|
26 units on a scale
Interval 0.0 to 75.0
|
18 units on a scale
Interval 0.0 to 60.0
|
SECONDARY outcome
Timeframe: Within 30 minutes of completion of procedureA 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.
Outcome measures
| Measure |
Lidocaine Arm
n=24 Participants
Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
|
Buffered Lidocaine
n=28 Participants
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.
|
|---|---|---|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)
Injection pain
|
25 units on a scale
Standard Deviation 19
|
19 units on a scale
Standard Deviation 17
|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)
Procedure pain
|
27 units on a scale
Standard Deviation 18
|
19 units on a scale
Standard Deviation 17
|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)
Cramping pain
|
19 units on a scale
Standard Deviation 16
|
18 units on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Within 30 minutes of completion of procedureA 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.
Outcome measures
| Measure |
Lidocaine Arm
n=24 Participants
Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
|
Buffered Lidocaine
n=28 Participants
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.
|
|---|---|---|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)
Injection pain
|
26 units on a scale
Interval 0.0 to 75.0
|
18 units on a scale
Interval 0.0 to 60.0
|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)
Procedure pain
|
25 units on a scale
Interval 0.0 to 63.0
|
13 units on a scale
Interval 0.0 to 54.0
|
|
Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)
Cramping pain
|
19 units on a scale
Interval 0.0 to 62.0
|
14 units on a scale
Interval 0.0 to 65.0
|
Adverse Events
Lidocaine Arm
Buffered Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
L. Stewart Massad, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place