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Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02063438
Recruitment Status : Recruiting
First Posted : February 14, 2014
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jules Lin, University of Michigan

Brief Summary:
The purpose of this study is to examine pain associated with thoracotomy (incision made during surgery to obtain access to your thoracic cavity) and how the closure technique may influence postoperative pain. Two types of routinely selected thoracotomy closure techniques will be examined; pericostal and intracostal sutures. The investigators hypothesize that intracostal sutures will result in less postoperative and chronic pain as a result of less compression of the intercostal nerve.

Condition or disease Intervention/treatment Phase
Hernia Lung Cancer Procedure: Pericostal suture technique Procedure: Intracostal suture technique Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
Study Start Date : February 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pericostal Suture Technique
A #2 Vicryl suture is placed along the superior aspect of the rib above the specific thoracic interspace. This suture is then passed below the inferior rib along the superior aspect of the next rib below. These sutures are then tied to approximate the ribs leaving enough room for the tip of a finger.
Procedure: Pericostal suture technique
Active Comparator: Intracostal Suture Technique
A handheld drill is used to drill holes in the rib below the specific thoracic interspace. A #2 Vicryl suture is passed through each of the holes and then passed along the superior aspect of the rib above the specific thoracic interspace. These sutures are then tied to approximate the ribs leaving enough room for the tip of a finger.
Procedure: Intracostal suture technique



Primary Outcome Measures :
  1. Severity of postoperative pain in the perioperative period. [ Time Frame: 2 weeks following surgery ]
  2. Intensity and incidence of chronic post-thoracotomy pain [ Time Frame: 6 months follwong surgery ]

Secondary Outcome Measures :
  1. Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique [ Time Frame: 6 months following surgery ]
  2. Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique [ Time Frame: 6 months following surgery ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing an elective procedure that will include a thoracotomy.
  • All patients will undergo epidural catheter placement.

Exclusion Criteria:

  • Previous thoracotomy on the operative side.
  • Previous history of chronic chest pain.
  • Previous history of thoracic trauma on the operative side.
  • Less than 18 years of age
  • Inability to provide informed consent or to complete testing or data collection
  • Need for a chest wall resection
  • Patients requiring other incisions in addition to a thoracotomy (i.e., Laparotomy, sternotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063438


Contacts
Contact: Jules Lin, MD 7349368857 juleslin@med.umich.edu
Contact: Shari L Barnett, BS 734-936-4561 shbailey@umich.edu

Locations
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48197
Contact: Shari L Barnett, BS    734-936-4561    shbailey@umich.edu   
Principal Investigator: Jules Lin, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jules Lin, MD UM Department of Surgery, Section of Thoracic Surgery

Publications of Results:

Other Publications:
Responsible Party: Jules Lin, Assistant Professor; Surgical Director, Lung Transplant, University of Michigan
ClinicalTrials.gov Identifier: NCT02063438     History of Changes
Other Study ID Numbers: HUM00082406
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Keywords provided by Jules Lin, University of Michigan:
Thoracotomy
Pain
Intracostal Suture
Pericostal Suture

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms