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Clinical Trials/NCT04618107
NCT04618107
Completed
Not Applicable

Principal Investigator

Dow University of Health Sciences1 site in 1 country130 target enrollmentJanuary 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tendon Injury - Hand
Sponsor
Dow University of Health Sciences
Enrollment
130
Locations
1
Primary Endpoint
active range of motion
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 31, 2020
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saba Kiran

Principal investigator

Dow University of Health Sciences

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.

Outcomes

Primary Outcomes

active range of motion

Time Frame: six weeks

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

Study Sites (1)

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