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NCT Number: NCT01898468

Post-Thoracotomy Closure Study

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.

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Key information

Conditions

Post Thoracotomy Pain Syndrome Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericostal Closure Technique

Procedure

Intracostal Closure Technique

Procedure

Primary outcomes

  1. Incidence and severity of post-thoracotomy pain

    Time frame: 3 months post surgery

    A Numerical Rating Score (NRS) for maximal daily pain from the patients surgical incision will also be measured (0 = no pain, 10 = worst possible pain) 3 months after surgery.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2013
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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