Continuous Infusion of Local Anesthetic for Post-operative Pain Control in Ukraine

Study Overview
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Brief Summary
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Ukraine is a newly sovereign country in Eastern Europe with a large burn population. With the collapse of the Soviet Union, burn programs have become decentralized and resources for maintaining facilities have dwindled. Patients frequently present with debilitating burn injuries and often do not receive necessary treatment secondary to limited resources and cost of treatment. The investigators have established an annual medical mission, outreach clinic and telemedicine relationship with hospitals and burn centers in Ukraine in an effort to improve burn care. One focus is post-operative pain control. The investigators have noticed a pattern of anxiety with children from the Ukraine surrounding dressing changes which they believe this is secondary to inadequate pain control in the immediate post-operative period including the initial dressing changes. The goal is to provide wound catheters with a continuous infusion of procaine in an attempt to reduce the pain experienced in the early post-operative period and specifically with dressing changes. There will be 200 participants, 12-65 years old who are receiving reconstructive plastic procedure with split-thickness skin grafts from lateral thigh in the study. 100 will receive the standard pain management Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM regimen and 100 will receive wound catheters with continuous procaine infusion for 48 hours with the standard Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM available for breakthrough pain. Pain scores will be assessed prior to dressing change, during dressing changes and at 30 minutes and 1 hour after dressing change.

Detailed Description
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There will be 200 participants, ages 12-65 years old who are receiving reconstructive plastic surgery with split-thickness skin grafts from the lateral thigh at 1 hospital in Ukrain. The first 100 will receive the standard pain regimen Analgin/Metamizole 1 g IM; Ketorolac 3%- 30 mg IM and the following 100 will receive catheters with continuous procaine infusion for 48 hours with the standard pain regimen available for breakthrough pain. All participants must be expected to remain inpatient for 48 hours post-operatively. Participants receiving continuous infusion of local anesthetic via a wound catheter will have the ON-Q PainBuster Post-Op Pain Relief System (I-Flow Corporation) tunneled subcutaneously while the patient is intra-operative. Catheter insertion sites will be covered with Steri-strips and covered with a transparent dressing to facilitate inspection of the insertion site for any erythema or discharge. Catheters will have a 10mL procaine 0.5% bolus intra-operative followed by an infusion delivered at 4-5mL/hr delivered by an elastomeric pump. Historically patients' pain complaints arise from skin graft donor sites rather then recipient sites. Patients will be assessed for pain scores on a scale of 0-10 (0= no pain and 10= worst possible pain) prior to dressing changes, during and 1 hour after dressing changes.

Conditions
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Pain

Intervention / Treatment
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* Device: Wound Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wound catheter<br>Wound catheters will be placed subcutaneously in the skin graft donor site in the lateral thigh while the patient remain intra-operative. The patients will receive a continuous infusion of procaine 0.5% at 4-5mL/hr using an elastomeric infusion device for 48 hours. Patients will be asked to asses pain on a 0-10 scale immediately prior to dressing changes, during dressing changes and 1 hour post dressing changes. | Device: Wound Catheter<br>* Wound catheter placement in split thickness skin graft donor site on the thigh with continuous infusion of procaine 0.5% at 4-5cc/hr for 48 hours.<br>|
| No Intervention: Control<br>Patients will receive the standard of care pain medication regimen of Analgin/Metamizole 1 g IM and Ketorolac 3%- 30 mg IM for post-operative pain treatment. The patients will be asked to rate pain on a scale of 0-10 immediately prior to dressing changes, during dressing changes and 1 hour after dressing changes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score with dressing changes | Patients will be asked to record a pain score prior to dressing changes, during dressing changes and 1 hour after dressing changes for a total of 48 hours until the wound catheter is removed | 1 hour with dressing changes over 48 hours |