Clinical trial NCT02063438: Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
Official title: Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Lung Cancer
Keywords: Thoracotomy
Pain
Intracostal Suture
Pericostal Suture
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of postoperative pain in the perioperative period.
timeFrame: 2 weeks following surgery
measure: Intensity and incidence of chronic post-thoracotomy pain
timeFrame: 6 months follwong surgery
Secondary outcomes:
measure: Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique
timeFrame: 6 months following surgery
measure: Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique
timeFrame: 6 months following surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
Study officials:
affiliation: UM Department of Surgery, Section of Thoracic Surgery
name: Jules Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/s0003-4975(03)00447-8.
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.
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. doi: 10.1016/j.jtcvs.2005.05.052.
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 15.
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.ejcts.2009.11.004. Epub 2009 Dec 1.
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: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.