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12 Years
65 Years
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Trial Information

There will be 128 participants, ages 12-65 years old who are receiving reconstructive
plastic surgery with split-thickness skin grafts STSG) from lateral thigh at 1 hospital in
Ukraine will be selected for participation. 64 will receive the standard pain management
(opioids IV only in first two hours after the surgery and NSIAD - Analgin/Metamizole 1 g IM;
Ketorolac 3%- 30 mg IM and Dexalgin PO) regimen and 64 will receive catheters with
continuous procaine infusion for 48 hours with the standard pain management regimen
available for breakthrough pain. All participants must be expected to remain inpatient for
48 hours post-operatively.

Study participants will be selected from those admitted for reconstructive surgery required
split-thickness skin grafts from the lateral thigh as part of their management.

Xeroformâ„¢ (bismuth tribromophenate) will be directly applied over the donor sites and
covered with an absorbent wound pad that was removed after 24 hours, allowing the gauze to

The ON-Q PainBuster Post-Op Pain Relief System (I-Flow Corporation) will be used in the
study with infusion of procaine 0.5% 4-5cc/hr. All grafts will be harvested with a Zimmer
air dermatome set at a nominal depth. ON-Q Soaker catheters will be placed into the donor
sites subcutaneously during the operation and immediately after STSG harvest. These
catheters contain multiple holes along the infusion segment that are distributed in a spiral
pattern, providing 360-degree drug distribution in the subcutaneous tissues directly under
the donor site. Catheter length (5, 7.5, and 10 inches) will be chosen for each patient in
accordance with the donor site length. The insertion site will be sealed with surgical
tissue adhesive to prevent leaks, secured with Steri-Strips, and will be covered with a
transparent dressing. A 10-ml procaine 0.5% bolus will be administered through each
catheter, and the elastomeric pump will be then connected to start the anesthetic infusion
before the conclusion of the case.

Data will be collected include age, sex, wound distribution, wound depth, wound total body
surface area (TBSA), wound causal mechanism (burn vs. other; and mechanism of burn), and
donor site surface area and location.

Post-operatively the following variable will be collected:

- requirements for Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM; vital signs
(BP,HR); Visual Analog Scores (VAS)

- Post-op day 1, analgesia requirements over past 24 hours, vital signs, VAS both pre,
during and post dressing change.

- Post-op day 2,analgesia requirements over past 24 hours, vital signs, VAS.

All participants will be asked to report a pain score based on a numerical rating scale of
0-10 (0 = no pain and 10 = worst pain possible) at 4-hour intervals and 1 hour following any
pain intervention.

Wound catheters will be placed under sterile conditions by the surgeon at the conclusion of
surgery. Catheter sites will be inspected every 24 hours for evidence of erythema or

Inclusion Criteria:

- those admitted for reconstructive surgery required split-thickness skin grafts from
the lateral thigh as part of their management

Exclusion Criteria:

- age less than 12 years

- known allergy to local anesthetics

- pseudocholinesterase deficiency,

- documented history of dementia/psychosis/delirium

- known neurologic conditions impairing pain sensation pathways

- pregnant, and breast feeding woman due to Ukrainian requirements

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Pain Score

Outcome Time Frame:

4 hour intervals for 48 hours

Safety Issue:


Principal Investigator

Gennadiy Fuzaylov, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

January 2015

Related Keywords:

  • Pain