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Compare the Outcomes of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus WALANT

A

Assiut University

Status

Completed

Conditions

Cut Flexor Hand
General Anesthesia
Walant

Treatments

Procedure: surgery of zone II cut flexor repair

Study type

Interventional

Funder types

Other

Identifiers

NCT04089124
zone II flexor repair

Details and patient eligibility

About

Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

Full description

Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management &mobilization to prevent adhesions and improve gliding but risk of rupture.

The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.

General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.

WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .

This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.

2)sheath and pulley damage are minimized, as flexor tendons are repaired through small transverse sheathotomy incisions 3) the surgeon can interview the patient during the procedure and assess the ability to comply with the postoperative regimen 4) the risks of general anesthesia are avoided in most patients. Negative effects of general anesthesia include nausea and vomiting, hospital admission for anesthesia recovery, exacerbation of comorbidity issues such as diabetes, aggressive flexion by the patient emerging from general anesthesia,and others

Enrollment

86 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Age less than sixteen years old or more than sixty years old .
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

86 participants in 2 patient groups

repair using General anesthesia ( control group)
Other group
Description:
Surgery repair zone II under GA
Treatment:
Procedure: surgery of zone II cut flexor repair
repair using Walant
Other group
Description:
Surgery repair zone II under WALANT
Treatment:
Procedure: surgery of zone II cut flexor repair

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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