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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063438
• Other study ID #: HUM00082406
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 15, 2020

Study information

• Verified date: September 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lung Cancer
• Pain, Postoperative

Intervention

Procedure:
• Pericostal suture technique

• Intracostal suture technique

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (8)

Allama AM. Intercostal muscle flap for decreasing pain after thoracotomy: a prospective randomized trial. Ann Thorac Surg. 2010 Jan;89(1):195-9. doi: 10.1016/j.athoracsur.2009.07.094. — View Citation

Bayram AS, Ozcan M, Kaya FN, Gebitekin C. Rib approximation without intercostal nerve compression reduces post-thoracotomy pain: a prospective randomized study. Eur J Cardiothorac Surg. 2011 Apr;39(4):570-4. doi: 10.1016/j.ejcts.2010.08.003. Epub 2010 Sep — View Citation

Cerfolio RJ, Bryant AS, Maniscalco LM. A nondivided intercostal muscle flap further reduces pain of thoracotomy: a prospective randomized trial. Ann Thorac Surg. 2008 Jun;85(6):1901-6; discussion 1906-7. doi: 10.1016/j.athoracsur.2008.01.041. — View Citation

Cerfolio RJ, Bryant AS, Patel B, Bartolucci AA. Intercostal muscle flap reduces the pain of thoracotomy: a prospective randomized trial. J Thorac Cardiovasc Surg. 2005 Oct;130(4):987-93. — View Citation

Cerfolio RJ, Price TN, Bryant AS, Sale Bass C, Bartolucci AA. Intracostal sutures decrease the pain of thoracotomy. Ann Thorac Surg. 2003 Aug;76(2):407-11; discussion 411-2. — View Citation

Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults — View Citation

Sakakura N, Usami N, Taniguchi T, Kawaguchi K, Okagawa T, Yokoyama M, Yokoi K. Assessment of long-term postoperative pain in open thoracotomy patients: pain reduction by the edge closure technique. Ann Thorac Surg. 2010 Apr;89(4):1064-70. doi: 10.1016/j.athoracsur.2010.01.015. — View Citation

Wu N, Yan S, Wang X, Lv C, Wang J, Zheng Q, Feng Y, Yang Y. A prospective, single-blind randomised study on the effect of intercostal nerve protection on early post-thoracotomy pain relief. Eur J Cardiothorac Surg. 2010 Apr;37(4):840-5. doi: 10.1016/j.ejc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of postoperative pain in the perioperative period.		2 weeks following surgery
Primary	Intensity and incidence of chronic post-thoracotomy pain		6 months follwong surgery
Secondary	Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique		6 months following surgery
Secondary	Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique		6 months following surgery