Clinical trial NCT06149962: Comparison Between Functional Outcomes of Flexor Tendon Repair Under WALANT and Brachial Plexus Block
Official title: Comparison Between Functional Outcomes of Flexor Tendon Repair Under Wide Awake Local Anesthesia no Tourniquet and Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexor Tendon Rupture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although outcomes after flexor tendon repair have reportedly improved with modern treatment, complications are common. Early passive and active motion protocols have improved outcomes of flexor tendon repairs. One potential complication of early motion occurs when the forces produced by this motion exceed the strength of the repair, which leads to gap formation and inhibits healing. Wide Awake Local Anesthesia No Tournique (WALANT) is a new anesthesia technique that has gained popularity among plastic surgeons. It was developed by Dr. Lalonde in Canada, and it involves the use of Lidocaine and adrenaline in the surgical site to control bleeding without the need for a tourniquet. Peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. Risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

Detailed description: WALANT can be applied in both elective and emergency surgeries and is commonly used for procedures involving the hand, wrist, and fingers, such as root tunnels syndromes, trigger finger, and fractures. However, it has some limitations and contraindications, including patients with coagulopathy or on anticoagulant therapy, those with allergies to any of the anesthesia components, or patients with a history of psychiatric disorders or aggressive behavior. Infraclavicular brachial plexus block (ICBPB) is widely used for anesthesia or analgesia during surgery on the hand and forearm. Today, it is most frequently performed using a sagittal ultrasound scan at the lateral infraclavicular fossa (LICF), where the local anesthetic is injected deep to the pectoral muscles. Peripheral nerve blocks are overall safe when performed correctly, there are rare but serious risks associated with them. Risks include block failure, bleeding, infection, damage to surrounding structures, permanent nerve injury, and intravascular uptake of local anesthetic resulting in systemic toxicity.

Eligibility criteria: Inclusion Criteria:

* Cooperative patients .
* age between 16-60 years.
* Acute flexor tendon injuries of the hand in both genders in medial four fingers.
* Sharp mechanism of injury.
* Single level injury zone 2.

Exclusion Criteria:

* 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
  * Patients with coagulopathy or on anticoagulant therapy
  * Patients with allergies to any of the anesthesia components

Primary outcomes:
measure: Quick Disabilities of the Arm, Shoulder, and Hand
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
affiliation: SOHAG U
name: Ahmed G ABDELMAGEED, A.PROF
role: STUDY_CHAIR
References:
citation: Dy CJ, Hernandez-Soria A, Ma Y, Roberts TR, Daluiski A. Complications after flexor tendon repair: a systematic review and meta-analysis. J Hand Surg Am. 2012 Mar;37(3):543-551.e1. doi: 10.1016/j.jhsa.2011.11.006. Epub 2012 Feb 6.
citation: Lalonde D. How the wide awake approach is changing hand surgery and hand therapy: inaugural AAHS sponsored lecture at the ASHT meeting, San Diego, 2012. J Hand Ther. 2013 Apr-Jun;26(2):175-8. doi: 10.1016/j.jht.2012.12.002. Epub 2013 Jan 5. No abstract available.
citation: Pollard R, Higham H, Quinlan J, Webster R, Lie J, Sivasubramaniam S. Nerve block site marking. Anaesthesia. 2019 Jan;74(1):123-124. doi: 10.1111/anae.14527. No abstract available.
citation: Sotthisopha T, Elgueta MF, Samerchua A, Leurcharusmee P, Tiyaprasertkul W, Gordon A, Finlayson RJ, Tran DQ. Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Block. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):571-574. doi: 10.1097/AAP.0000000000000629.