HerniaNCT02063438
Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
A study testing Pericostal suture technique and Intracostal suture technique in people with Hernia and Lung Cancer, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hernia, Lung Cancer
- What is being tested?
- Pericostal suture technique and Intracostal suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an elective procedure that will include a thoracotomy.
- All patients will undergo epidural catheter placement.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48197
About this study
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
- Being tested
- Pericostal suture technique, Intracostal suture technique
- Keywords
- Thoracotomy, Pain, Intracostal Suture, Pericostal Suture
- Medical subject headings
- Hernia, Lung Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericostal suture techniqueProcedure or surgery
Intracostal suture techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pericostal Suture Technique | Active comparator | 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. Receives: Procedure: Pericostal suture technique |
| Intracostal Suture Technique | Active comparator | 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. Receives: Procedure: Intracostal suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of postoperative pain in the perioperative period.
Measured: 2 weeks following surgery
Intensity and incidence of chronic post-thoracotomy pain
Measured: 6 months follwong surgery
Secondary outcomes (2)
Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Measured: 6 months following surgery
Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Measured: 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jules Lin, University of Michigan
- Investigators
- Jules Lin, MD, Principal investigator, UM Department of Surgery, Section of Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063438
- Sponsor's protocol ID
- HUM00082406
- Status last verified
- Sep 2020
- First submitted
- 30 Jan 2014
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20103234Sakakura 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.
PubMed 20338308Cerfolio 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.
PubMed 12902074Cerfolio 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.
PubMed 18498792Cerfolio 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.
PubMed 16214509Bayram 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.
PubMed 20833556Wu 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.
PubMed 19954996Gordon 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.
PubMed 20400379
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02063438
- Acronym / sponsor ID
- HUM00082406
- Conditions
- Hernia, Lung Cancer
- Keywords
- Thoracotomy, Pain, Intracostal Suture, Pericostal Suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericostal Suture Technique | Active comparator | Procedure: Pericostal suture techniqueA #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. |
| Intracostal Suture Technique | Active comparator | Procedure: Intracostal suture techniqueA 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing an elective procedure that will include a thoracotomy.
- All patients will undergo epidural catheter placement.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericostal suture technique | Procedure or surgery | Pericostal Suture Technique |
| Intracostal suture technique | Procedure or surgery | Intracostal Suture Technique |
Primary outcome
Severity of postoperative pain in the perioperative period.
Time frame: 2 weeks following surgery
Intensity and incidence of chronic post-thoracotomy pain
Time frame: 6 months follwong surgery
2 secondary outcomes
Complication rates between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Time frame: 6 months following surgery
Length of hospital stay and associated hospital costs between subjects undergoing pericostal versus intracostal thoracotomy closure technique
Time frame: 6 months following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 20103234Allama 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.
- Background: PubMed 20338308Sakakura 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 publication: PubMed 12902074Cerfolio 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 publication: PubMed 18498792Cerfolio 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 publication: PubMed 16214509Cerfolio 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 publication: PubMed 20833556Bayram 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 publication: PubMed 19954996Wu 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 publication: PubMed 20400379Gordon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jules Lin, MD principal investigator
UM Department of Surgery, Section of Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericostal suture technique and Intracostal suture technique in people with Hernia and Lung Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of postoperative pain in the perioperative period. (time frame: 2 weeks following surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063438, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.