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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Flexor Tendon Rupture
• Intervention / Treatment: Procedure: FLEXOR TENDON REPAIR

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: OMAR M HUSSEIN, resident; Phone Number: 01097195683; Email: OMARMOHAMED@MED.SOHAG.EDU.EG
• Study Contact Backup: Name: TAREK A ABULEZZ, professor

Study Locations

• Egypt
  • Sohag, Egypt, Sohag
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WALANT; Flexor Tendon Repair under Wide-Awake Local Anesthesia No Tourniquet	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.
Active Comparator: BRACHIAL BLOCK; Flexor Tendon Repair under Brachial Plexus Block	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Disabilities of the Arm, Shoulder, and Hand	Quick Disabilities of the Arm, Shoulder, and Hand using (DASH) scores	6 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Ahmed G ABDELMAGEED, A.PROF, SOHAG U

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): July 10, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: November 26, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: soh_med_23_06_07ms

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No