Post-Thoracotomy Closure Study

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

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 Overview

• Status: Completed
• Conditions: Post Thoracotomy Pain Syndrome
• Intervention / Treatment: Procedure: Intracostal Closure Technique; Procedure: Pericostal Closure Technique

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intracostal Closure Technique; Closure involves drilling four evenly spaced holes using a 5-mm bit attached to the end of a Stryker drill into the bed of the sixth rib.	Procedure: Intracostal Closure Technique
Active Comparator: Pericostal Closure Technique; Closure involves placing sutures around the ribs in the standard pericostal fashion	Procedure: Pericostal Closure Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of post-thoracotomy pain	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.	3 months post surgery

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Hance Clarke, MD, Toronto General Hospital, University Health Network

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Post surgical pain; Neuropathic pain symptoms; Intracostal Closure Technique; Pericostal Suture Closure Technique; Post thoracotomy pain
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: UHN13-5894