Lidocaine Analgesia For Removal Of Wound Vac Dressings

NCT01126359 | Completed Results

• 1 other identifier: 29398
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Wound Vacuum Assisted Dressings; Lidocaine; Dressing change; Pain management; palliative care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Break-through Narcotic Requirement

  20 minutes

Study Arms (2)

Lidocaine then Placebo-Saline

PLACEBO COMPARATOR

Drug: Lidocaine; Drug: Placebo-Saline

Placebo-Saline then Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine; Drug: Placebo-Saline

Interventions

Lidocaine DRUG

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

Also known as: xylocaine

Lidocaine then Placebo-Saline; Placebo-Saline then Lidocaine

Placebo-Saline DRUG

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

Also known as: 0.9% normal saline

Lidocaine then Placebo-Saline; Placebo-Saline then Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (4)

• 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.

  PMID: 12374481 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.

  PMID: 11839329 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.

  PMID: 18279921 BACKGROUND

• 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.

  PMID: 23343829 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Erik Kubiak
• Organization: Department of Orthopaedics

Erik.Kubiak@hsc.utah.edu

801-587-5404

Study Officials

• Erik N Kubiak, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 29, 2014
• Results First Posted: May 29, 2014

Record last verified: 2014-05

Locations

US (1)