Clinical trial NCT04089124: Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT
Official title: Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cut Flexor Hand
Walant
General Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 86
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: repair zone II cut flexor of hand under GA and Walant
Primary purpose: TREATMENT

Brief summary: Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

Detailed description: Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management \&mobilization to prevent adhesions and improve gliding but risk of rupture.

The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.

General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.

WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .

This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.

2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others

Eligibility criteria: Inclusion Criteria:

* Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
* Cooperative patients aged between 16-60 years.
* Sharp mechanism of injury
* Single level injury

Exclusion Criteria:

* Age less than sixteen years old or more than sixty years old .
* Associated fractures close to the tendon injury.
* Vascular injury requiring revascularization
* Multiple level injury
* Combined flexor and extensor laceration
* Insufficient skin and soft tissue coverage
* Tendon substance loss

Primary outcomes:
measure: range of motions using Jamar finger goniometer
timeFrame: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)
Secondary outcomes:
measure: complications
timeFrame: baseline
measure: Healing vs failure of repair
timeFrame: baseline
measure: DASH score using DASH questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
citation: Wolfe SW, Pederson WC, Hotchkiss RN, Kozin SH , Cohen MS. Green's Operative Hand Surgery E-book. Elsevier Health sciences ; 2016 Feb 24.
citation: Canale ST, Beaty JH, Campbell WC. Campbell's operative orthopaedics. 2013.
citation: Lalonde D. Wide Awake Hand Surgery . CRC press. 2016 Jan 27.
citation: Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
citation: Farnebo S, Chang J. Practical management of tendon disorders in the hand. Plast Reconstr Surg. 2013 Nov;132(5):841e-853e. doi: 10.1097/PRS.0b013e3182a48ccf.
citation: Steiner MM, Calandruccio JH. Use of Wide-awake Local Anesthesia No Tourniquet in Hand and Wrist Surgery. Orthop Clin North Am. 2018 Jan;49(1):63-68. doi: 10.1016/j.ocl.2017.08.008.
citation: Pires Neto PJ, Moreira LA, Las Casas PP. Is it safe to use local anesthesia with adrenaline in hand surgery? WALANT technique. Rev Bras Ortop. 2017 Jul 19;52(4):383-389. doi: 10.1016/j.rboe.2017.05.006. eCollection 2017 Jun-Jul.
citation: Lalonde DH, Kozin S. Tendon disorders of the hand. Plast Reconstr Surg. 2011 Jul;128(1):1e-14e. doi: 10.1097/PRS.0b013e3182174593.
citation: Lalonde DH. Latest Advances in Wide Awake Hand Surgery. Hand Clin. 2019 Feb;35(1):1-6. doi: 10.1016/j.hcl.2018.08.002.
citation: Higgins A, Lalonde DH, Bell M, McKee D, Lalonde JF. Avoiding flexor tendon repair rupture with intraoperative total active movement examination. Plast Reconstr Surg. 2010 Sep;126(3):941-945. doi: 10.1097/PRS.0b013e3181e60489.
citation: Festen-Schrier VJMM, Amadio PC. Wide Awake Surgery as an Opportunity to Enhance Clinical Research. Hand Clin. 2019 Feb;35(1):93-96. doi: 10.1016/j.hcl.2018.08.003.
citation: Osada D, Fujita S, Tamai K, Yamaguchi T, Iwamoto A, Saotome K. Flexor tendon repair in zone II with 6-strand techniques and early active mobilization. J Hand Surg Am. 2006 Jul-Aug;31(6):987-92. doi: 10.1016/j.jhsa.2006.03.012.
citation: Wong YR, Lee CS, Loke AM, Liu X, Suzana MJ I, Tay SC. Comparison of Flexor Tendon Repair Between 6-Strand Lim-Tsai With 4-Strand Cruciate and Becker Technique. J Hand Surg Am. 2015 Sep;40(9):1806-11. doi: 10.1016/j.jhsa.2015.05.007. Epub 2015 Jun 30.
citation: Kleinert HE, Spokevicius S, Papas NH. History of flexor tendon repair. J Hand Surg Am. 1995 May;20(3 Pt 2):S46-52. doi: 10.1016/s0363-5023(95)80169-3. No abstract available.