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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Toronto General Hospital, Toronto, Ontario, Canada
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
Intracostal Closure Technique
ProcedurePrimary outcomes
-
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.
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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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