Pain
Conditions
Keywords
Wound Vacuum Assisted Dressings, Lidocaine, Dressing change, Pain management, palliative care
Brief summary
The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.
Interventions
DRUGLidocaine
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
DRUGPlacebo-Saline
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. wounds to which a split-thickness autologous skin graft applied; 2. infected wounds after debridement; 3. open fracture wounds; 4. acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint); 5. fasciotomy wounds after compartment syndrome; 6. chronic non-healing wounds; 7. surgical wounds that are difficult to close due to tension; or 8. wounds with external fixation pins or tubes with irritation or drainage.
Exclusion criteria
1. allergy to lidocaine; 2. allergy to the polyurethane foam or impermeable seal; 3. malignancy associated with the wound; 4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein); 5. pregnancy as diagnosed by urine pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score | 20 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Break-through Narcotic Requirement | 20 minutes | Patient 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (20-minutes) | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Visual Analog Scale Pain Score
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).
Time frame: 20 minutes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lidocaine | Visual Analog Scale Pain Score | During VAC change | 6.5 Visial Analog Pain Score (VAS) |
| Lidocaine | Visual Analog Scale Pain Score | 5 min post-VAC change | 4.4 Visial Analog Pain Score (VAS) |
| Lidocaine | Visual Analog Scale Pain Score | 10 min post VAC change | 3.2 Visial Analog Pain Score (VAS) |
| Lidocaine | Visual Analog Scale Pain Score | 20 min post VAC change | 2.4 Visial Analog Pain Score (VAS) |
| Placebo-Saline | Visual Analog Scale Pain Score | 20 min post VAC change | 4.2 Visial Analog Pain Score (VAS) |
| Placebo-Saline | Visual Analog Scale Pain Score | During VAC change | 8.9 Visial Analog Pain Score (VAS) |
| Placebo-Saline | Visual Analog Scale Pain Score | 10 min post VAC change | 4.7 Visial Analog Pain Score (VAS) |
| Placebo-Saline | Visual Analog Scale Pain Score | 5 min post-VAC change | 6.4 Visial Analog Pain Score (VAS) |
| Lidocaine Minus Placebo-Saline Difference | Visual Analog Scale Pain Score | 20 min post VAC change | -1.8 Visial Analog Pain Score (VAS) |
| Lidocaine Minus Placebo-Saline Difference | Visual Analog Scale Pain Score | 5 min post-VAC change | -2.0 Visial Analog Pain Score (VAS) |
| Lidocaine Minus Placebo-Saline Difference | Visual Analog Scale Pain Score | 10 min post VAC change | -1.5 Visial Analog Pain Score (VAS) |
| Lidocaine Minus Placebo-Saline Difference | Visual Analog Scale Pain Score | During VAC change | -2.4 Visial Analog Pain Score (VAS) |
Secondary
Break-through Narcotic Requirement
Patient 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.
Time frame: 20 minutes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lidocaine | Break-through Narcotic Requirement | 20 min post VAC change | 0.0 Narcotic Requirements (mg) |
| Lidocaine | Break-through Narcotic Requirement | During VAC change | 1.3 Narcotic Requirements (mg) |
| Lidocaine | Break-through Narcotic Requirement | 5 min post-VAC change | 0.8 Narcotic Requirements (mg) |
| Lidocaine | Break-through Narcotic Requirement | 10 min post VAC change | 0.2 Narcotic Requirements (mg) |
| Placebo-Saline | Break-through Narcotic Requirement | 10 min post VAC change | 0.4 Narcotic Requirements (mg) |
| Placebo-Saline | Break-through Narcotic Requirement | During VAC change | 3.0 Narcotic Requirements (mg) |
| Placebo-Saline | Break-through Narcotic Requirement | 20 min post VAC change | 0.3 Narcotic Requirements (mg) |
| Placebo-Saline | Break-through Narcotic Requirement | 5 min post-VAC change | 1.1 Narcotic Requirements (mg) |
| Lidocaine Minus Placebo-Saline Difference | Break-through Narcotic Requirement | During VAC change | -1.7 Narcotic Requirements (mg) |
| Lidocaine Minus Placebo-Saline Difference | Break-through Narcotic Requirement | 5 min post-VAC change | -0.4 Narcotic Requirements (mg) |
| Lidocaine Minus Placebo-Saline Difference | Break-through Narcotic Requirement | 10 min post VAC change | -0.2 Narcotic Requirements (mg) |
| Lidocaine Minus Placebo-Saline Difference | Break-through Narcotic Requirement | 20 min post VAC change | -0.3 Narcotic Requirements (mg) |