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Post-Thoracotomy Closure Study

NCT01898468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-12-08

No results posted yet for this study

Summary

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.

Conditions

  • Post Thoracotomy Pain Syndrome

Interventions

PROCEDURE

Pericostal Closure Technique

PROCEDURE

Intracostal Closure Technique

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Hance Clarke, MD · Toronto General Hospital, University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898468 on ClinicalTrials.gov