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

NCT ID: NCT06149962

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2024-07-10

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.

Conditions

Flexor Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WALANT

Flexor Tendon Repair under Wide-Awake Local Anesthesia No Tourniquet

Group Type: ACTIVE_COMPARATOR

FLEXOR TENDON REPAIR

Intervention Type: PROCEDURE

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.

BRACHIAL BLOCK

Flexor Tendon Repair under Brachial Plexus Block

Group Type: ACTIVE_COMPARATOR

FLEXOR TENDON REPAIR

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Omar Mohamed Hussein

Resident-plastic department-sohag hospital university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed G ABDELMAGEED, A.PROF

Role: STUDY_CHAIR

SOHAG U

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

OMAR M HUSSEIN, resident

Role: CONTACT

Phone: 01097195683

Email: OMARMOHAMED@MED.SOHAG.EDU.EG

TAREK A ABULEZZ, professor

Role: CONTACT

Facility Contacts

Magdy M Amin, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 22317947 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23294825 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30511750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28723837 (View on PubMed)

Other Identifiers

soh_med_23_06_07ms

Identifier Type: -

Identifier Source: org_study_id