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Lidocaine Analgesia For Removal Of Wound Vac Dressings

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Pain

Treatments

Drug: Placebo-Saline
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

11 participants in 2 patient groups, including a placebo group

Lidocaine then Placebo-Saline
Placebo Comparator group
Treatment:
Drug: Lidocaine
Drug: Placebo-Saline
Placebo-Saline then Lidocaine
Active Comparator group
Treatment:
Drug: Lidocaine
Drug: Placebo-Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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