Trial Outcomes & Findings for Lidocaine Analgesia For Removal Of Wound Vac Dressings (NCT NCT01126359)
NCT ID: NCT01126359
Last Updated: 2014-05-29
Results Overview
Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
20 minutes
Results posted on
2014-05-29
Participant Flow
Participant milestones
| Measure |
Lidocaine Then Placebo-Saline
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
|
Placebo-Saline Then Lidocaine
Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
|
|---|---|---|
|
First Intervention (20-minutes)
STARTED
|
5
|
6
|
|
First Intervention (20-minutes)
COMPLETED
|
5
|
5
|
|
First Intervention (20-minutes)
NOT COMPLETED
|
0
|
1
|
|
Dressing Replacement/Healing (48-hours)
STARTED
|
5
|
5
|
|
Dressing Replacement/Healing (48-hours)
COMPLETED
|
5
|
5
|
|
Dressing Replacement/Healing (48-hours)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (20-minutes)
STARTED
|
5
|
5
|
|
Second Intervention (20-minutes)
COMPLETED
|
5
|
5
|
|
Second Intervention (20-minutes)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine Then Placebo-Saline
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
|
Placebo-Saline Then Lidocaine
Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
|
|---|---|---|
|
First Intervention (20-minutes)
Physician Decision
|
0
|
1
|
Baseline Characteristics
Lidocaine Analgesia For Removal Of Wound Vac Dressings
Baseline characteristics by cohort
| Measure |
All Study Participants
n=11 Participants
Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 minutesVisial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).
Outcome measures
| Measure |
Lidocaine
n=10 Participants
All patients who received lidocaine prior to VAC dressing change.
|
Placebo-Saline
n=11 Participants
All patients who received placebo-saline prior to VAC dressing change.
|
Lidocaine Minus Placebo-Saline Difference
n=11 Participants
Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
|
|---|---|---|---|
|
Visual Analog Scale Pain Score
During VAC change
|
6.5 Visial Analog Pain Score (VAS)
Interval 5.5 to 7.4
|
8.9 Visial Analog Pain Score (VAS)
Interval 8.0 to 9.7
|
-2.4 Visial Analog Pain Score (VAS)
Interval -3.0 to -1.7
|
|
Visual Analog Scale Pain Score
5 min post-VAC change
|
4.4 Visial Analog Pain Score (VAS)
Interval 3.2 to 5.7
|
6.4 Visial Analog Pain Score (VAS)
Interval 5.3 to 7.5
|
-2.0 Visial Analog Pain Score (VAS)
Interval -3.3 to -0.8
|
|
Visual Analog Scale Pain Score
10 min post VAC change
|
3.2 Visial Analog Pain Score (VAS)
Interval 2.0 to 4.5
|
4.7 Visial Analog Pain Score (VAS)
Interval 3.6 to 5.8
|
-1.5 Visial Analog Pain Score (VAS)
Interval -2.8 to -0.1
|
|
Visual Analog Scale Pain Score
20 min post VAC change
|
2.4 Visial Analog Pain Score (VAS)
Interval 1.3 to 3.5
|
4.2 Visial Analog Pain Score (VAS)
Interval 3.2 to 5.1
|
-1.8 Visial Analog Pain Score (VAS)
Interval -3.0 to -0.6
|
SECONDARY outcome
Timeframe: 20 minutesPatient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.
Outcome measures
| Measure |
Lidocaine
n=10 Participants
All patients who received lidocaine prior to VAC dressing change.
|
Placebo-Saline
n=11 Participants
All patients who received placebo-saline prior to VAC dressing change.
|
Lidocaine Minus Placebo-Saline Difference
n=11 Participants
Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
|
|---|---|---|---|
|
Break-through Narcotic Requirement
20 min post VAC change
|
0.0 Narcotic Requirements (mg)
Interval -0.4 to 0.3
|
0.3 Narcotic Requirements (mg)
Interval 0.0 to 0.6
|
-0.3 Narcotic Requirements (mg)
Interval -0.7 to 0.1
|
|
Break-through Narcotic Requirement
During VAC change
|
1.3 Narcotic Requirements (mg)
Interval 0.2 to 2.3
|
3.0 Narcotic Requirements (mg)
Interval 2.0 to 3.9
|
-1.7 Narcotic Requirements (mg)
Interval -2.3 to -1.1
|
|
Break-through Narcotic Requirement
5 min post-VAC change
|
0.8 Narcotic Requirements (mg)
Interval 0.0 to 1.6
|
1.1 Narcotic Requirements (mg)
Interval 0.4 to 1.9
|
-0.4 Narcotic Requirements (mg)
Interval -1.0 to -0.2
|
|
Break-through Narcotic Requirement
10 min post VAC change
|
0.2 Narcotic Requirements (mg)
Interval -0.3 to 0.6
|
0.4 Narcotic Requirements (mg)
Interval 0.0 to 0.8
|
-0.2 Narcotic Requirements (mg)
Interval -0.8 to 0.4
|
Adverse Events
First Intervention (Lidocaine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
First Intervention (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Second Intervention (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Second Intervention (Lidocaine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place