Tendon Injury - HandNCT04618107
Wide Awake Surgery for Tendon Repair in Hand Trauma
A study testing Wide awake surgery and General anaesthesia in people with Tendon Injury - Hand, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tendon Injury - Hand
- What is being tested?
- Wide awake surgery and General anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Jan 2020to 30 Sep 2020
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of either gender of age 15 years or above.
- All of the patients with hand injuries with tendon repair required, operated within the hospital premises
Who cannot join
- Patients allergic to agents of local anesthesia.
- Patients with anxiety symptoms
- Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.
- Patients with associated nerve injuries.
- Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.
- Patients with massive contamination, crush injuries or infection which needs to be addressed and treated prior to definitive repair.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Principal Investigator
Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia.
Read the detailed description
All patients aged 15 or above with hand trauma resulting in tendon injuries were included.65 patients undergoing tendon repair in wide awake anaesthesia were grouped as approach arm and another 65 patients of general anaesthesia group were kept as control arm.Range of motion of corresponding tendons were measured at completion of sixth postoperative week using goniometer.Total active range of motion were calculated according to criteria given by Strickland method and American Society for Surgery ofthe Hand (ASSH).
Functional outcomes were compared among two groups.
- Conditions
- Tendon Injury - Hand
- Being tested
- Wide awake surgery, General anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide awake surgeryProcedure or surgery
Wide awake local anaesthesia was used to perform tendon repair surgeries.Local anaesthetic injections given using 27 gauze needle in subcutaneous tissue plane.Tendon repair performed using modified Kessler repair.Outcome of surgery assesed at sixth postoprative week.
General anaesthesiaProcedure or surgery
Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week
| Study group | Role | What they receive |
|---|---|---|
| Wide awake surgery | Experimental | Wide awake local anaesthesia was used as mode of aneasthesia for tendon repair surgery. Functional outcome of in terms of active range of motion was calculated via Strickland method and American Society for the surgery of the hand criteria at sixth week of surgery using goniometer Receives: Procedure: Wide awake surgery |
| General anaesthesia | Active comparator | Tendon repair surgeries were performed under general anaesthesia. Functional outcome of in terms of active range of motion was calculated via Strickland method and American Society for the surgery of the hand criteria at sixth week of surgery using goniometer Receives: Procedure: General anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
active range of motion
active range of motion assesd by strickland and American Society for surgery criteria
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start31 Jan 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tendon Injury - HandStudies of the same condition, open and under way.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saba Kiran, Dow University of Health Sciences
- Investigators
- Saba Kiran, MBBS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618107
- Sponsor's protocol ID
- 1316
- Status last verified
- Oct 2020
- First submitted
- 31 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Neill N, Abdall-Razak A, Norton E, Kumar A, Shah H, Khatkar H, Alsafi Z, Agha R. Use of Wide-Awake Local Anaesthetic No Tourniquet (WALANT) in upper limb and hand surgery: A systematic review protocol. Int J Surg Protoc. 2020 Mar 13;20:8-12. doi: 10.1016/j.isjp.2020.03.001. eCollection 2020.
PubMed 32258835Fulchignoni C, Bonetti MA, Rovere G, Ziranu A, Maccauro G, Pataia E. Wide awake surgery for flexor tendon primary repair: A literature review. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8668. doi: 10.4081/or.2020.8668. eCollection 2020 Jun 29.
PubMed 32913601Libberecht K, Lafaire C, Van Hee R. Evaluation and functional assessment of flexor tendon repair in the hand. Acta Chir Belg. 2006 Sep-Oct;106(5):560-5. doi: 10.1080/00015458.2006.11679952.
PubMed 17168270
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT04618107
- Acronym / sponsor ID
- 1316
- Conditions
- Tendon Injury - Hand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Nov 2020 (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.
Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia.
Detailed description
All patients aged 15 or above with hand trauma resulting in tendon injuries were included.65 patients undergoing tendon repair in wide awake anaesthesia were grouped as approach arm and another 65 patients of general anaesthesia group were kept as control arm.Range of motion of corresponding tendons were measured at completion of sixth postoperative week using goniometer.Total active range of motion were calculated according to criteria given by Strickland method and American Society for Surgery ofthe Hand (ASSH).
Functional outcomes were compared among two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide awake surgery | Experimental | Procedure: Wide awake surgeryWide awake local anaesthesia was used as mode of aneasthesia for tendon repair surgery. Functional outcome of in terms of active range of motion was calculated via Strickland method and American Society for the surgery of the hand criteria at sixth week of surgery using goniometer |
| General anaesthesia | Active comparator | Procedure: General anaesthesiaTendon repair surgeries were performed under general anaesthesia. Functional outcome of in terms of active range of motion was calculated via Strickland method and American Society for the surgery of the hand criteria at sixth week of surgery using goniometer |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of either gender of age 15 years or above.
- All of the patients with hand injuries with tendon repair required, operated within the hospital premises
Key exclusion criteria (6 listed)
- Patients allergic to agents of local anesthesia.
- Patients with anxiety symptoms
- Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.
- Patients with associated nerve injuries.
- Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.
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 |
|---|---|---|
| Wide awake surgeryWide awake local anaesthesia was used to perform tendon repair surgeries.Local anaesthetic injections given using 27 gauze needle in subcutaneous tissue plane.Tendon repair performed using modified Kessler repair.Outcome of surgery assesed at sixth postoprative week. | Procedure or surgery | Wide awake surgery |
| General anaesthesiaTendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week | Procedure or surgery | General anaesthesia |
Primary outcome
active range of motion
Time frame: six weeks
active range of motion assesd by strickland and American Society for surgery criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 32258835O'Neill N, Abdall-Razak A, Norton E, Kumar A, Shah H, Khatkar H, Alsafi Z, Agha R. Use of Wide-Awake Local Anaesthetic No Tourniquet (WALANT) in upper limb and hand surgery: A systematic review protocol. Int J Surg Protoc. 2020 Mar 13;20:8-12. doi: 10.1016/j.isjp.2020.03.001. eCollection 2020.
- Background: PubMed 32913601Fulchignoni C, Bonetti MA, Rovere G, Ziranu A, Maccauro G, Pataia E. Wide awake surgery for flexor tendon primary repair: A literature review. Orthop Rev (Pavia). 2020 Jun 25;12(Suppl 1):8668. doi: 10.4081/or.2020.8668. eCollection 2020 Jun 29.
- Background: PubMed 17168270Libberecht K, Lafaire C, Van Hee R. Evaluation and functional assessment of flexor tendon repair in the hand. Acta Chir Belg. 2006 Sep-Oct;106(5):560-5. doi: 10.1080/00015458.2006.11679952.
- Individual participant dataSharing planned: No
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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.
Saba Kiran, MBBS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide awake surgery and General anaesthesia in people with Tendon Injury - Hand, run by Dow University of Health Sciences at 1 site in Pakistan.
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 2 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: finished, as of the sponsor's last update on 5 Nov 2020. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
active range of motion (time frame: six weeks). 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 NCT04618107, which also lists 3 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 5 Nov 2020.