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Post-Thoracotomy Closure Study

NCT ID: NCT01898468

Last Updated: 2020-12-08

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-12-31

Brief Summary

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Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.

Detailed Description

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Conditions

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Post Thoracotomy Pain Syndrome

Keywords

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Neuropathic pain symptoms Intracostal Closure Technique Pericostal Suture Closure Technique Post surgical pain Post thoracotomy pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intracostal Closure Technique

Closure involves drilling four evenly spaced holes using a 5-mm bit attached to the end of a Stryker drill into the bed of the sixth rib.

Group Type ACTIVE_COMPARATOR

Intracostal Closure Technique

Intervention Type PROCEDURE

Pericostal Closure Technique

Closure involves placing sutures around the ribs in the standard pericostal fashion

Group Type ACTIVE_COMPARATOR

Pericostal Closure Technique

Intervention Type PROCEDURE

Interventions

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Pericostal Closure Technique

Intervention Type PROCEDURE

Intracostal Closure Technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients 18-88 years age
* Patients undergoing surgery with an open thoracotomy incision

Exclusion Criteria

* Patient refusal
* Inability to give informed consent
* Concurrent drug addiction or methadone use
* Present chronic pain syndrome
* Significant psychiatric illness excluding depression
* Cannot understand English, read or write in English independently
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hance Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN13-5894

Identifier Type: -

Identifier Source: org_study_id