PainNCT01863940
Continuous Infusion of Local Anesthetic for Post-operative Pain Control in Ukraine
A study testing Wound Catheter in people with Pain, run by Massachusetts General Hospital at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Wound Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUkraine
- Study dates
- Aug 2013to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- those admitted for reconstructive surgery required split-thickness skin grafts from the lateral thigh as part of their management
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Wound Catheter
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour with dressing changes over 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2022
- Study completionMar 2022
Why it stopped: Political unrest in study country
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennadiy Fuzaylov, Massachusetts General Hospital
- Investigators
- Gennadiy Fuzaylov, M.D., Principal investigator, Massachusetts General HospitalCheryl Bline, M.D., Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863940
- Sponsor's protocol ID
- 2012P002299
- Status last verified
- Aug 2022
- First submitted
- 23 May 2013
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
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. No abstract available.
PubMed 23202873Hernandez 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.
PubMed 23271060Thomas 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.
PubMed 6347012Baig 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.
PubMed 16427556
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion of Local Anesthetic for Post-operative Pain Control in Ukraine
- ClinicalTrials.gov ID
- NCT01863940
- Acronym / sponsor ID
- 2012P002299
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Political unrest in study country
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wound catheter | Experimental | Device: Wound CatheterWound 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. |
| 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- those admitted for reconstructive surgery required split-thickness skin grafts from the lateral thigh as part of their management
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound CatheterWound 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. | Device | Wound catheter |
Primary outcome
Pain Score with dressing changes
Time frame: 1 hour with dressing changes over 48 hours
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
Results and safety
The study was stopped early (reason given: Political unrest in study country). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 23202873Fuzaylov 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.
- Background: PubMed 23271060Hernandez 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.
- Background: PubMed 6347012Thomas 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.
- Background: PubMed 16427556Baig 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennadiy Fuzaylov, M.D. principal investigator
Massachusetts General Hospital
Cheryl Bline, M.D. study director
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Catheter in people with Pain, run by Massachusetts General Hospital at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Political unrest in study country). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score with dressing changes (time frame: 1 hour with dressing changes over 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863940, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.