Wide Awake Surgery for Tendon Repair in Hand Trauma

October 31, 2020 updated by: Saba Kiran, Dow University of Health Sciences

Principal Investigator

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75080
        • Saba Kiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wide awake surgery
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
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.
Active Comparator: General anaesthesia
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
Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
active range of motion
Time Frame: six weeks
active range of motion assesd by strickland and American Society for surgery criteria
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Saba Kiran, MBBS, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

October 31, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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