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Completed

NCT Number: NCT01126359

Lidocaine Analgesia For Removal Of Wound Vac Dressings

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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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • wounds to which a split-thickness autologous skin graft applied;
  • infected wounds after debridement;
  • open fracture wounds;
  • acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
  • fasciotomy wounds after compartment syndrome;
  • chronic non-healing wounds;
  • surgical wounds that are difficult to close due to tension; or
  • wounds with external fixation pins or tubes with irritation or drainage.

Exclusion criteria

  • allergy to lidocaine;
  • allergy to the polyurethane foam or impermeable seal;
  • malignancy associated with the wound;
  • extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
  • pregnancy as diagnosed by urine pregnancy test.

Treatment and study plan

Lidocaine

Drug

Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.

Other names: xylocaine

Placebo-Saline

Drug

Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.

Other names: 0.9% normal saline

Primary outcomes

  1. Visual Analog Scale Pain Score

    Time frame: 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 outcomes

  1. Break-through Narcotic Requirement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 19, 2010
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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