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

Primary Purpose

Hernia, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pericostal suture technique

Intracostal suture technique

About this trial

This is an interventional treatment trial for Hernia focused on measuring Thoracotomy, Pain, Intracostal Suture, Pericostal Suture

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Pericostal Suture Technique

Intracostal Suture Technique

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Severity of postoperative pain in the perioperative period.

Intensity and incidence of chronic post-thoracotomy pain

Secondary Outcome Measures

Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique

Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique

Full Information

NCT ID

NCT02063438

First Posted

January 30, 2014

Last Updated

September 24, 2020

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT02063438

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

July 15, 2020 (Actual)

Study Completion Date

July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Lung Cancer

Keywords

Thoracotomy, Pain, Intracostal Suture, Pericostal Suture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

255 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pericostal Suture Technique

Arm Type

Active Comparator

Arm Description

Arm Title

Intracostal Suture Technique

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Pericostal suture technique

Intervention Type

Procedure

Intervention Name(s)

Intracostal suture technique

Primary Outcome Measure Information:

Title

Severity of postoperative pain in the perioperative period.

Time Frame

2 weeks following surgery

Title

Intensity and incidence of chronic post-thoracotomy pain

Time Frame

6 months follwong surgery

Secondary Outcome Measure Information:

Title

Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique

Time Frame

6 months following surgery

Title

Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique

Time Frame

6 months following surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jules Lin, MD

Organizational Affiliation

UM Department of Surgery, Section of Thoracic Surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Medical Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20103234

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.

Results Reference

background

PubMed Identifier

20338308

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.

Results Reference

background

PubMed Identifier

12902074

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.

Results Reference

result

PubMed Identifier

18498792

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.

Results Reference

result

PubMed Identifier

16214509

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.

Results Reference

result

PubMed Identifier

20833556

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.

Results Reference

result

PubMed Identifier

19954996

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.

Results Reference

result

PubMed Identifier

20400379

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.

Results Reference

result

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

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