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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Wound Catheter (Device)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Gennadiy Fuzaylov, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Cheryl Bline, M.D., Study Director, Affiliation: Massachusetts General Hospital

Overall contact:
Gennadiy Fuzaylov, M.D., Phone: 617-726-8904, Email: gfuzzaylov@partners.org

Summary

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.

Clinical Details

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

Primary outcome: Pain Score with dressing changes

Detailed 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.

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Gennadiy Fuzaylov, M.D., Phone: 617-726-8904, Email: gfuzzaylov@partners.org

Burn Unit, Municipal Hospital #8, Lviv, Ukraine; Not yet recruiting
Alexander Dunaev, Phone: 011-380-91-916-3877
Alexander Dunaev, Principal Investigator
Additional Information

Related publications:

Fuzaylov G, Driscoll DN, Volfson I. A plan to improve pediatric burn care in Ukraine. J Burn Care Res. 2013 Mar-Apr;34(2):e119-20. doi: 10.1097/BCR.0b013e318267c942.

Hernandez JL, Savetamal A, Crombie RE, Cholewczynski W, Atweh N, Possenti P, Schulz JT 3rd. Use of continuous local anesthetic infusion in the management of postoperative split-thickness skin graft donor site pain. J Burn Care Res. 2013 Jul-Aug;34(4):e257-62. doi: 10.1097/BCR.0b013e3182721735.

Thomas DF, Lambert WG, Williams KL. The direct perfusion of surgical wounds with local anaesthetic solution: an approach to postoperative pain? Ann R Coll Surg Engl. 1983 Jul;65(4):226-9.

Baig MK, Zmora O, Derdemezi J, Weiss EG, Nogueras JJ, Wexner SD. Use of the ON-Q pain management system is associated with decreased postoperative analgesic requirement: double blind randomized placebo pilot study. J Am Coll Surg. 2006 Feb;202(2):297-305.

Starting date: August 2013
Last updated: July 28, 2013

Page last updated: August 23, 2015

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