Lidocaine Analgesia For Removal Of Wound Vac Dressings

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126359
• Other study ID #: 29398
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: May 21, 2014
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: May 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
• Placebo-Saline
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	20 minutes	No
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.	20 minutes	No