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

NCT ID: NCT02063438

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2020-07-15

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.

Conditions

Hernia; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pericostal suture technique

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

Intracostal suture technique

Intervention Type: PROCEDURE

Interventions

Pericostal suture technique

Intervention Type: PROCEDURE

Intracostal suture technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jules Lin

Assistant Professor; Surgical Director, Lung Transplant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jules Lin, MD

Role: PRINCIPAL_INVESTIGATOR

UM Department of Surgery, Section of Thoracic Surgery

Locations

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20103234 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20338308 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12902074 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18498792 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16214509 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20833556 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19954996 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20400379 (View on PubMed)

Other Identifiers

HUM00082406

Identifier Type: -

Identifier Source: org_study_id