Trial Outcomes & Findings for Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes (NCT NCT00585325)
NCT ID: NCT00585325
Last Updated: 2018-03-07
Results Overview
A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)
COMPLETED
NA
15 participants
During dressing change
2018-03-07
Participant Flow
A total of 15 patients were enrolled with 41 VAC dressing changes. Patients could be enrolled into more than one arm.
Unit of analysis: VAC dressing changes
Participant milestones
| Measure |
Instilled 1% Lidocaine
5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
|
Instilled Placebo (0.9% Normal Saline)
receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
|
|---|---|---|
|
Overall Study
STARTED
|
10 20
|
13 21
|
|
Overall Study
COMPLETED
|
9 14
|
12 18
|
|
Overall Study
NOT COMPLETED
|
1 6
|
1 3
|
Reasons for withdrawal
| Measure |
Instilled 1% Lidocaine
5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
|
Instilled Placebo (0.9% Normal Saline)
receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes
Baseline characteristics by cohort
| Measure |
Instilled 1% Lidocaine
n=14 VAC dressing changes
5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
|
Instilled Placebo (0.9% Normal Saline)
n=18 VAC dressing changes
receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
|
Total
n=32 VAC dressing changes
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
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
12 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During dressing changeA pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)
Outcome measures
| Measure |
Instilled 1% Lidocaine
n=14 VAC dressing changes
5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
Instilled 1% Lidocaine: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
|
Instilled Placebo (0.9% Normal Saline)
n=18 VAC dressing changes
receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
Placebo (0.9% Normal Saline): .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
|
|---|---|---|
|
Pain During Dressing Change
|
6.36 units on a scale
Standard Deviation 2.56
|
6.94 units on a scale
Standard Deviation 3.11
|
Adverse Events
Instilled 1% Lidocaine
Instilled Placebo (0.9% Normal Saline)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cindy Schmitz, RN, MS, NP
University of Wisconsin-Madison
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place