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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine then Placebo-Saline | Placebo Comparator |
| |
| Placebo-Saline then Lidocaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik N Kubiak, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12374481 | Background | Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11. doi: 10.5435/00124635-200209000-00002. | |
| 11839329 | Background | Garner GB, Ware DN, Cocanour CS, Duke JH, McKinley BA, Kozar RA, Moore FA. Vacuum-assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens. Am J Surg. 2001 Dec;182(6):630-8. doi: 10.1016/s0002-9610(01)00786-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (20-minutes) |
|
| ||||||||||||||||||
| Dressing Replacement/Healing (48-hours) |
| |||||||||||||||||||
| Second Intervention (20-minutes) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | Visial Analog Pain Score (VAS) | 20 minutes |
|
48 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First Intervention (Lidocaine) |
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Overall subjectivity of pain and dosing of narcotic medications, all male cohort, timing of wound VAC changes, did not define the ideal lidocaine dosing for VAC changes or dosing method.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erik Kubiak | Department of Orthopaedics | 801-587-5404 | Erik.Kubiak@hsc.utah.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo-Saline | Drug | Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube. |
|
|
| 18279921 | Background | Choe JH, Kwak KW, Hong JH, Lee HM. Efficacy of lidocaine spray as topical anesthesia for outpatient rigid cystoscopy in women: a prospective, randomized, double-blind trial. Urology. 2008 Apr;71(4):561-6. doi: 10.1016/j.urology.2007.11.057. Epub 2008 Feb 15. |
| 23343829 | Result | Christensen TJ, Thorum T, Kubiak EN. Lidocaine analgesia for removal of wound vacuum-assisted closure dressings: a randomized double-blinded placebo-controlled trial. J Orthop Trauma. 2013 Feb;27(2):107-12. doi: 10.1097/BOT.0b013e318251219c. |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Narcotic Requirements (mg) | 20 minutes |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | First Intervention (Placebo) | 0 | 6 | 0 | 6 |
| EG002 | Second Intervention (Placebo) | 0 | 5 | 0 | 5 |
| EG003 | Second Intervention (Lidocaine) | 0 | 5 | 0 | 5 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
|
| 10 min post VAC change |
|
| 20 min post VAC change |
|