Wide Awake Surgery for Tendon Repair in Hand Trauma
Primary Purpose
Tendon Injury - Hand
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Wide awake surgery
General anaesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Tendon Injury - Hand
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Saba Kiran
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wide awake surgery
General anaesthesia
Arm Description
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
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
Outcomes
Primary Outcome Measures
active range of motion
active range of motion assesd by strickland and American Society for surgery criteria
Secondary Outcome Measures
Full Information
NCT ID
NCT04618107
First Posted
October 31, 2020
Last Updated
October 31, 2020
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04618107
Brief Title
Wide Awake Surgery for Tendon Repair in Hand Trauma
Official Title
Principal Investigator
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injury - Hand
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wide awake surgery
Arm Type
Experimental
Arm Description
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
Arm Title
General anaesthesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Wide awake surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anaesthesia
Intervention Description
Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week
Primary Outcome Measure Information:
Title
active range of motion
Description
active range of motion assesd by strickland and American Society for surgery criteria
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Kiran, MBBS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saba Kiran
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75080
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32258835
Citation
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.
Results Reference
background
PubMed Identifier
32913601
Citation
Fulchignoni 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.
Results Reference
background
PubMed Identifier
17168270
Citation
Libberecht 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.
Results Reference
background
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Wide Awake Surgery for Tendon Repair in Hand Trauma
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