NCT06149962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

August 6, 2023

Last Update Submit

November 26, 2023

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (1)

  • Quick Disabilities of the Arm, Shoulder, and Hand

    Quick Disabilities of the Arm, Shoulder, and Hand using (DASH) scores

    6 months

Study Arms (2)

WALANT

ACTIVE COMPARATOR

Flexor Tendon Repair under Wide-Awake Local Anesthesia No Tourniquet

Procedure: FLEXOR TENDON REPAIR

BRACHIAL BLOCK

ACTIVE COMPARATOR

Flexor Tendon Repair under Brachial Plexus Block

Procedure: FLEXOR TENDON REPAIR

Interventions

FLEXOR TENDON REPAIRPROCEDURE

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 BLOCKWALANT

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related 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.

    PMID: 22317947BACKGROUND

  • 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.

    PMID: 23294825BACKGROUND

  • 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.

    PMID: 30511750BACKGROUND

  • 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.

    PMID: 28723837BACKGROUND

Study Officials

  • Ahmed G ABDELMAGEED, A.PROF

    SOHAG U

    STUDY CHAIR

Central Study Contacts

OMAR M HUSSEIN, resident

CONTACT

01097195683OMARMOHAMED@MED.SOHAG.EDU.EG

TAREK A ABULEZZ, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-plastic department-sohag hospital university

Study Record Dates

First Submitted

August 6, 2023

First Posted

November 29, 2023

Study Start

July 10, 2023

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

EG(1)