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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02063438
Other study ID # HUM00082406
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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