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

Mass General Brigham

Status: Terminated

Conditions: Pain

Treatments: Device: Wound Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01863940

2012P002299

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Wound catheter

Experimental group

Description:

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.

Treatment:

Device: Wound Catheter

Control

No Intervention group

Description:

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.