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Completed

NCT Number: NCT04618107

Wide Awake Surgery for Tendon Repair in Hand Trauma

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.

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Key information

Conditions

Tendon Injury - Hand

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saba Kiran

Karachi, Sindh, 75080, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wide awake surgery

Procedure

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

Procedure

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

Primary outcomes

  1. active range of motion

    Time frame: six weeks

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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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