Comparison Between Functional Outcomes of Flexor Tendon Repair Under WALANT and Brachial Plexus Block

Flexor Tendon Rupture Clinical Trial

Official title:

Comparison Between Functional Outcomes of Flexor Tendon Repair Under Wide Awake Local Anesthesia no Tourniquet and Brachial Plexus Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149962
• Other study ID #: soh_med_23_06_07ms
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: November 2023
• Source: Sohag University
• Contact: OMAR M HUSSEIN, resident
• Phone: 01097195683
• Email: OMARMOHAMED[@]MED.SOHAG.EDU.EG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Rupture
• Rupture

Intervention

Procedure:
• FLEXOR TENDON REPAIR
we will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture under WALANT technique and brachial plexus block.

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Disabilities of the Arm, Shoulder, and Hand	Quick Disabilities of the Arm, Shoulder, and Hand using (DASH) scores	6 months