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

NCT01863940 | Terminated DMC

• 1 other identifier: 2012P002299
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Wound catheter

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Wound Catheter DEVICE

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.

Wound catheter

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Burn Unit, Municipal Hospital #8

Lviv, Ukraine

Location

Related Publications (4)

• 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. No abstract available.

  PMID: 23202873 BACKGROUND

• 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.

  PMID: 23271060 BACKGROUND

• 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.

  PMID: 6347012 BACKGROUND

• 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. doi: 10.1016/j.jamcollsurg.2005.10.022.

  PMID: 16427556 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gennadiy Fuzaylov, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Cheryl Bline, M.D.

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gennadiy Fuzaylov, M.D.

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

UA (1)