Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Incidence and severity of post-thoracotomy pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary 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.
Secondary Outcomes
No secondary outcomes reported