Clinical Trials Directory

Trials / Completed

CompletedNCT04089124

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

Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
86 (actual)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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

Conditions

Interventions

TypeNameDescription
PROCEDUREsurgery of zone II cut flexor repairwe will repair tendon of FDP only using 6 strand technique using PDS 4/0 core suture - prolene 6/0 running suture

Timeline

Start date
2020-02-01
Primary completion
2021-12-15
Completion
2022-06-30
First posted
2019-09-13
Last updated
2022-11-30

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04089124. Inclusion in this directory is not an endorsement.