PainNCT01126359

Lidocaine Analgesia For Removal Of Wound Vac Dressings

A study testing Lidocaine in people with Pain, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: Lidocaine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Aug 2008to Mar 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

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
Being tested: Lidocaine, Placebo-Saline
Keywords: Wound Vacuum Assisted Dressings, Lidocaine, Dressing change, Pain management, palliative care
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LidocaineDrug
Also called xylocaine
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
Placebo-SalineDrug
Also called 0.9% normal saline
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.

Study groups in NCT01126359
Study group	Role	What they receive
Lidocaine then Placebo-Saline	Placebo comparator	Not described Receives: Drug: Lidocaine; Drug: Placebo-Saline
Placebo-Saline then Lidocaine	Active comparator	Not described Receives: Drug: Lidocaine; Drug: Placebo-Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 20 minutes

Secondary outcomes (1)

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.
Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008Mar 2010

First posted19 May 2010 (estimated)
Study startAug 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01126359
Sponsor's protocol ID: 29398
Status last verified: May 2014
First submitted: 17 May 2010
Last updated: 29 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 12374481
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.
PubMed 11839329
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.
PubMed 18279921
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.
PubMed 23343829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
ClinicalTrials.gov ID: NCT01126359
Acronym / sponsor ID: 29398
Conditions: Pain
Keywords: Wound Vacuum Assisted Dressings, Lidocaine, Dressing change, Pain management, palliative care
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: Aug 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 19 May 2010 (estimated)
Results: Posted 29 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Lidocaine then Placebo-Saline	Placebo comparator	Drug: Lidocaine, Drug: Placebo-Saline
Placebo-Saline then Lidocaine	Active comparator	Drug: Lidocaine, Drug: Placebo-Saline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LidocaineAlso: xylocaineInterventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.	Drug	Lidocaine then Placebo-Saline, Placebo-Saline then Lidocaine
Placebo-SalineAlso: 0.9% normal salineControl dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.	Drug	Lidocaine then Placebo-Saline, Placebo-Saline then Lidocaine

Primary outcome

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).

1 secondary outcome

Break-through Narcotic Requirement
Time frame: 20 minutes

Results and safety

Results posted to the registry on 29 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine Then Placebo-Saline	5	5
Placebo-Saline Then Lidocaine	6	5

Primary outcome: Visual Analog Scale Pain Score

Time frame: 20 minutes. Mean (95% Confidence Interval). Unit: Visial Analog Pain Score (VAS)

Measure	Lidocaine n = 10	Placebo-Saline n = 11	Lidocaine Minus Placebo-Saline Difference n = 11
During VAC change	6.5 (5.5 to 7.4)	8.9 (8.0 to 9.7)	-2.4 (-3.0 to -1.7)
5 min post-VAC change	4.4 (3.2 to 5.7)	6.4 (5.3 to 7.5)	-2.0 (-3.3 to -0.8)
10 min post VAC change	3.2 (2.0 to 4.5)	4.7 (3.6 to 5.8)	-1.5 (-2.8 to -0.1)
20 min post VAC change	2.4 (1.3 to 3.5)	4.2 (3.2 to 5.1)	-1.8 (-3.0 to -0.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 48 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
First Intervention (Lidocaine)	0 of 5 (0%)	0 of 5 (0%)	Not reported
First Intervention (Placebo)	0 of 6 (0%)	0 of 6 (0%)	Not reported
Second Intervention (Placebo)	0 of 5 (0%)	0 of 5 (0%)	Not reported
Second Intervention (Lidocaine)	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12374481Webb 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.
Background: PubMed 11839329Garner 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.
Background: PubMed 18279921Choe 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.
Results publication: PubMed 23343829Christensen 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erik N Kubiak, MD principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine in people with Pain, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale Pain Score (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126359, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.