Flexor Tendon RuptureNCT06149962
Comparison Between Functional Outcomes of Flexor Tendon Repair Under WALANT and Brachial Plexus Block
A study testing FLEXOR TENDON REPAIR in people with Flexor Tendon Rupture, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Flexor Tendon Rupture
- What is being tested?
- FLEXOR TENDON REPAIR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2023to 10 Jul 2024
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
TAREK A ABULEZZ, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor
About this study
Official title: Comparison Between Functional Outcomes of Flexor Tendon Repair Under Wide Awake Local Anesthesia no Tourniquet and Brachial Plexus Block
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.
Read the 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
- Being tested
- FLEXOR TENDON REPAIR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXOR TENDON REPAIRProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| WALANT | Active comparator | Flexor Tendon Repair under Wide-Awake Local Anesthesia No Tourniquet Receives: Procedure: FLEXOR TENDON REPAIR |
| BRACHIAL BLOCK | Active comparator | Flexor Tendon Repair under Brachial Plexus Block Receives: Procedure: FLEXOR TENDON REPAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Disabilities of the Arm, Shoulder, and Hand
Quick Disabilities of the Arm, Shoulder, and Hand using (DASH) scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start10 Jul 2023
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Flexor Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Hussein, Sohag University
- Investigators
- Ahmed G ABDELMAGEED, A.PROF, Study chair, SOHAG U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149962
- Sponsor's protocol ID
- soh_med_23_06_07ms
- Status last verified
- Nov 2023
- First submitted
- 6 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: YES
Publications
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.
PubMed 22317947Lalonde 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.
PubMed 23294825Pollard 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.
PubMed 30511750Sotthisopha 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.
PubMed 28723837
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Functional Outcomes of Flexor Tendon Repair Under Wide Awake Local Anesthesia no Tourniquet and Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT06149962
- Acronym / sponsor ID
- soh_med_23_06_07ms
- Conditions
- Flexor Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 29 Nov 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WALANT | Active comparator | Procedure: FLEXOR TENDON REPAIRFlexor Tendon Repair under Wide-Awake Local Anesthesia No Tourniquet |
| BRACHIAL BLOCK | Active comparator | Procedure: FLEXOR TENDON REPAIRFlexor Tendon Repair under Brachial Plexus Block |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Associated fractures close to the tendon injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEXOR TENDON REPAIRwe 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. | Procedure or surgery | BRACHIAL BLOCK, WALANT |
Primary outcome
Quick Disabilities of the Arm, Shoulder, and Hand
Time frame: 6 months
Quick Disabilities of the Arm, Shoulder, and Hand using (DASH) scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 22317947Dy 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.
- Background: PubMed 23294825Lalonde 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.
- Background: PubMed 30511750Pollard 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.
- Background: PubMed 28723837Sotthisopha 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.
- Individual participant dataSharing planned: Undecided. YES
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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 A ABULEZZ, professor contact
Ahmed G ABDELMAGEED, A.PROF study chair
SOHAG U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXOR TENDON REPAIR in people with Flexor Tendon Rupture, run by Sohag University at 1 site in Egypt.
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 5 inclusion and 8 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 OMAR M HUSSEIN, resident (01097195683, OMARMOHAMED@MED.SOHAG.EDU.EG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Disabilities of the Arm, Shoulder, and Hand (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149962, which also lists 4 linked publications.
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 29 Nov 2023.