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

September 24, 2020 updated by: Jules Lin, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48197
        • University of Michigan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Time Frame: 6 months following surgery
6 months following surgery
Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Time Frame: 6 months following surgery
6 months following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Jules Lin, MD, UM Department of Surgery, Section of Thoracic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

January 30, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00082406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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