Flexor Tendon InjuryNCT03752957
Wide-Awake Local Anesthesia For Flexor Tendon Repair
An observational study of Flexor Tendon Injury, run by Assiut University.
Trial summary
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Tendon Injury
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Assiut University Hospital , microsurgery unit
Who may be able to join
- over the age of 18 acute single or multiple digit complete flexor tendon lacerations in zones I or II
Who cannot join
- gross wound contamination
- segmental tendon loss
- associated finger fractures
- complex or multisystem injuries
- complex or multisystem injuries
- mangled hand injuries
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Wide-Awake Local Anesthesia No Tourniquet Versus. Local/General Anesthesia for Flexor Tendon Repair
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bow stringing and quadriplegia. Tendon surgery is unique because it should ensure tendon gliding after surgery Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.
Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine). It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.
Read the detailed description
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia. Tendon surgery is unique because it should ensure tendon gliding after surgery It has been a standard practice to obtain local or general anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been changed in recent years...
Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.
The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine).8 It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.The "smoking gun" paper that established that procaine was the actual cause of finger deaths published in the Journal of the American Medical Association that found batches of procaine with a pH of 1 destined for injection into humans.
- Conditions
- Flexor Tendon Injury
- Keywords
- Wide-Awake Local Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative complication rate
Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
Measured: average 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Slah Eldin Koriem, Assiut University
- Investigators
- Tarek Abdula ELgamal, Study chair, Assiut UniversityAmr Elsaid Ali, Study chair, Assiut UniversityMohamed Mostafa Kotb, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752957
- Sponsor's protocol ID
- WideAwake Flexor Tendon Repair
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wide-Awake Local Anesthesia No Tourniquet Versus. Local/General Anesthesia for Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT03752957
- Acronym / sponsor ID
- WideAwake Flexor Tendon Repair
- Conditions
- Flexor Tendon Injury
- Keywords
- Wide-Awake Local Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bow stringing and quadriplegia. Tendon surgery is unique because it should ensure tendon gliding after surgery Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.
Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine). It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.
Detailed description
Primary repair for flexor tendon lacerations remain the standard of care. However, despite recent advances in knowledge of tendon healing, suture material, and post-operative protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications encountered include adhesion formation, development of joint contractures, tendon rupture, triggering, bowstringing and quadrigia. Tendon surgery is unique because it should ensure tendon gliding after surgery It has been a standard practice to obtain local or general anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been changed in recent years...
Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This method allows the tendon to move actively during surgery to test tendon function intraoperatively and to ensure the tendon is properly repaired before leaving the operating table.
The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures, revise pulley reconstruction, or de-bulk tendons before wound closure Wide awake hand surgery is well described by its other name, WALANT which stands for wide awake local anaesthesia no tourniquet. The only two medications most patients are given for wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the belief developed among surgeons that epinephrine causes finger necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine).8 It was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died from procaine injection alone than from procaine plus epinephrine injection .no lost finger no case require phentolamine in many studies.The "smoking gun" paper that established that procaine was the actual cause of finger deaths published in the Journal of the American Medical Association that found batches of procaine with a pH of 1 destined for injection into humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Assiut University Hospital , microsurgery unit
Key inclusion criteria (1 listed)
- over the age of 18 acute single or multiple digit complete flexor tendon lacerations in zones I or II
Key exclusion criteria (6 listed)
- gross wound contamination
- segmental tendon loss
- associated finger fractures
- complex or multisystem injuries
- complex or multisystem injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post operative complication rate
Time frame: average 2 months
Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Flexor Tendon Injury
Recruiting
Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
Recruiting
Virtual Reality Combined With Active Mobilization Post Flexor Tendon Repair
Flexor Tendon Injury
Recruiting
Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
Flexor Tendon Injury, Tendon Injury - Hand
Recruiting
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Flexor Tendon Injury, Rehabilitation Program
Not yet recruiting
Comparing Two Skin Incisions for Flexor Tendon Repair
Flexor Tendon Injury, Incision, Surgical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Abdula ELgamal study chair
Assiut University
Amr Elsaid Ali study chair
Assiut University
Mohamed Mostafa Kotb study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Flexor Tendon Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Salah Eldin Koriem (+201002766810, Mohamed.elshreef.mes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative complication rate (time frame: average 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.