NCT04618107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

October 31, 2020

Last Update Submit

October 31, 2020

Conditions

Tendon Injury - Hand

Outcome Measures

Primary Outcomes (1)

  • active range of motion

    active range of motion assesd by strickland and American Society for surgery criteria

    six weeks

Study Arms (2)

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

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

Procedure: General anaesthesia

Interventions

Wide awake surgeryPROCEDURE

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.

Wide awake surgery
General anaesthesiaPROCEDURE

Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week

General anaesthesia

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saba Kiran

Karachi, Sindh, 75080, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 32258835BACKGROUND

  • 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.

    PMID: 32913601BACKGROUND

  • 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.

    PMID: 17168270BACKGROUND

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Saba Kiran, MBBS

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 5, 2020

Study Start

January 31, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 5, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)