Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
NCT ID: NCT02501720
Last Updated: 2015-07-17
Study Results
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Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.
Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.
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Detailed Description
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Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.
Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,000 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,000 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.
To the investigators' knowledge no study has so far been done to compare the outcome of release of post burn flexion contractures under tumescent technique with general anesthesia or under tourniquet control with general anesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tourniquet Group
Post burn flexion contractures will be released under tourniquet control
post burn flexion contractures release under tourniquet control
post burn flexion contractures will be released under tourniquet control
Contracture release and application of FTSG
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
Tumescent technique group
Post burn flexion contractures will be released using Tumescent solution
post burn flexion contractures release using tumescent solution
post burn flexion contractures will be released using tumescent solution
Contracture release and application of FTSG
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
Interventions
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post burn flexion contractures release under tourniquet control
post burn flexion contractures will be released under tourniquet control
post burn flexion contractures release using tumescent solution
post burn flexion contractures will be released using tumescent solution
Contracture release and application of FTSG
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
Eligibility Criteria
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Inclusion Criteria
* Possible to cover the defect with full thickness skin graft
* age range of 3 to 12 years.
* Patients of both genders
Exclusion Criteria
* Children with any history of bleeding diathesis or coagulopathy.
* Children with any co-morbid condition making any contraindication of general anesthesia.
* Patients having previous history of vascular insufficiency like Raynaud's disease or phenomenon, severe peripheral vascular disease and peripheral neuropathy.
* The patient having allergic hypersensitivity to epinephrine, lidocaine.
3 Years
12 Years
ALL
No
Sponsors
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King Edward Medical University
OTHER
Responsible Party
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Muhammad Mustehsan Bashir
Associate professor of Plastic Surgery
Central Contacts
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References
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Spuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.
Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15.
Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014 Feb;30(1):1-6. doi: 10.1016/j.hcl.2013.08.015. Epub 2013 Nov 9.
Teo I, Lam W, Muthayya P, Steele K, Alexander S, Miller G. Patients' perspective of wide-awake hand surgery--100 consecutive cases. J Hand Surg Eur Vol. 2013 Nov;38(9):992-9. doi: 10.1177/1753193412475241. Epub 2013 Jan 24.
Al Youha S, Lalonde DH. Update/Review: changing of use of local anesthesia in the hand. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e150. doi: 10.1097/GOX.0000000000000095. eCollection 2014 May.
Prasetyono TO. Tourniquet-Free Hand Surgery Using the One-per-Mil Tumescent Technique. Arch Plast Surg. 2013 Mar;40(2):129-33. doi: 10.5999/aps.2013.40.2.129. Epub 2013 Mar 11.
Shridharani S, Manson P, Magarakis M et al. The safety and efficacy of epinephrine in hand surgery: a systematic review of the literature and international survey. European Journal of Plastic Surgery. 2014; 37: 183-188.
Gumus N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8.
Other Identifiers
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2335
Identifier Type: -
Identifier Source: org_study_id
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