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NCT Number: NCT02063438

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

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.

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Key information

Conditions

Hernia Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48197, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericostal suture technique

Procedure

Intracostal suture technique

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Feb 14, 2014
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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