Skip to content

Post-Thoracotomy Closure Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01898468
Enrollment
90
Registered
2013-07-12
Start date
2013-06-30
Completion date
2019-12-31
Last updated
2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Thoracotomy Pain Syndrome

Keywords

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

Brief 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.

Interventions

PROCEDUREPericostal Closure Technique
PROCEDUREIntracostal Closure Technique

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence and severity of post-thoracotomy pain3 months post surgeryA 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026