Post-Thoracotomy Closure Study

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01898468

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Thoracotomy Pain Syndrome	Procedure: Pericostal Closure Technique Procedure: Intracostal Closure Technique	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence and severity of post-thoracotomy pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto General Hospital, University Health Network	Toronto	Ontario	Canada	M5G 2C4
2	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01898468

Other Study ID Numbers:

UHN13-5894

First Posted:

Jul 12, 2013

Last Update Posted:

Dec 8, 2020

Last Verified:

Oct 1, 2018

Keywords provided by University Health Network, Toronto

Neuropathic pain symptoms

Intracostal Closure Technique

Pericostal Suture Closure Technique

Post surgical pain

Post thoracotomy pain

Additional relevant MeSH terms:

Syndrome

Study Results

No Results Posted as of Dec 8, 2020