Wide Awake Surgery for Tendon Repair in Hand Trauma

Not Applicable

Completed

• Conditions: Tendon Injury - Hand
• Interventions: Procedure: Wide awake surgery; Procedure: General anaesthesia

• Registration Number: NCT04618107
• Lead Sponsor: Dow University of Health Sciences

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.

Study Timeline

• Study Start: 2020-01-31
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-10-31
• Last Update Submitted: 2020-10-31
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wide awake surgery	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
General anaesthesia	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

Primary Outcome Measures

Name	Time	Method
active range of motion	six weeks	active range of motion assesd by strickland and American Society for surgery criteria

Trial Locations

Locations (1)

Saba Kiran; 🇵🇰 Karachi, Sindh, Pakistan