Wide Awake Surgery for Tendon Repair in Hand Trauma

NCT ID: NCT04618107

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Tendon Injury - Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Wide awake surgery

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

General anaesthesia

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

General anaesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Saba Kiran

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saba Kiran, MBBS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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Saba Kiran

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 32258835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32913601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17168270 (View on PubMed)

Other Identifiers

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1316

Identifier Type: -

Identifier Source: org_study_id