Wide Awake Surgery for Tendon Repair in Hand Trauma

Tendon Injury - Hand Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618107
• Other study ID #: 1316
• Status: Completed
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

1. Patients of either gender of age 15 years or above.

2. All of the patients with hand injuries with tendon repair required, operated within the hospital premises

Exclusion Criteria:

1. Patients allergic to agents of local anesthesia.

2. Patients with anxiety symptoms

3. Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.

4. Patients with associated nerve injuries.

5. Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.

6. Patients with massive contamination, crush injuries or infection which needs to be addressed and treated prior to definitive repair.

Related Conditions & MeSH terms

• Tendon Injuries
• Tendon Injury - Hand

Intervention

Procedure:
• Wide awake 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 anaesthesia
Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week

Locations

Country	Name	City	State
Pakistan	Saba Kiran	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	active range of motion	active range of motion assesd by strickland and American Society for surgery criteria	six weeks