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

Not Applicable

Completed

• Conditions: Lung Cancer; Hernia

• Registration Number: NCT02063438
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study Start: 2014-02
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Severity of postoperative pain in the perioperative period.	2 weeks following surgery
Intensity and incidence of chronic post-thoracotomy pain	6 months follwong surgery

Secondary Outcome Measures

Name	Time	Method
Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique	6 months following surgery
Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique	6 months following surgery

Trial Locations

Locations (1)

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States