Clinical trial NCT01863940: Continuous Infusion of Local Anesthetic for Post-operative Pain Control in Ukraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Pain Score with dressing changes
timeFrame: 1 hour with dressing changes over 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: Burn Unit, Municipal Hospital #8
Study officials:
affiliation: Massachusetts General Hospital
name: Gennadiy Fuzaylov, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Cheryl Bline, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.