Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children

Flexion Contracture Clinical Trial

Official title:

Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02501720
• Other study ID #: 2335
• Status: Not yet recruiting
• Phase: N/A
• First received: July 12, 2015
• Last updated: July 16, 2015
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: King Edward Medical University
• Contact: Muhammad M Bashir, F.C.P.S
• Phone: 923336517745
• Email: mmbashir1[@]gmail.com
• Is FDA regulated: No
• Health authority: Pakistan:Institutional Review Board King Edward Medical University
• Study type: Interventional

Clinical Trial Summary

Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.

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.

Description:

Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children with post burn flexion contractures involving volar aspect of palm and fingers

• 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 recurrent post burn contractures.

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Contracture
• Flexion Contracture
• Hand Burns

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

References & Publications (8)

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. — View Citation

Gümüs N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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.

Spuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time to secure graft	Operative time to secure graft will be measured by calculating the time taken to secure per square centimeter of graft.; Time (T) in minutes to secure per cm2 of graft = Total operative time / size of graft secured in cm2 measured by transparent graft paper In tourniquet group total operative time will be measured as total time taken from start of applying tourniquet including time taken for exsanguinations to the time till completion of dressing.; In tumescent group total operative time will be measured as total time taken from start of injecting the tumescent solution including waiting time for tumescent solution to produce maximum vasoconstriction (25 minutes) to the time till completion of dressing	Time of surgery	No
Primary	Percentage graft taken	It will be measured by the percentage of graft take at 14th post-operative day. Percentage graft take = Graft secured at the time of operation measured by using transparent graph paper / graft take at 14th post-operative day measured by using transparent graph paper.	14th day post surgery	No
Primary	Post-operative pain (FLACC scale)	Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at first hour postoperatively taking time of arrival in the ward as zero hour	At First hour after arrival in ward following surgery	No
Primary	Post-operative pain (FLACC scale)	Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 6th hour postoperatively taking time of arrival in the ward as zero hour.	At 6th hour after arrival in ward following surgery	No
Primary	Post-operative pain (FLACC scale)	Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 12th hour postoperatively taking time of arrival in the ward as zero hour.	At 12th hour after arrival in ward following surgery	No
Primary	Post-operative pain (FLACC scale)	Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 24th hour postoperatively taking time of arrival in the ward as zero hour.	At 24th hour after arrival in ward following surgery	No