Post Thoracotomy Pain SyndromeNCT01898468
Post-Thoracotomy Closure Study
A study testing Pericostal Closure Technique and Intracostal Closure Technique in people with Post Thoracotomy Pain Syndrome, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thoracotomy Pain Syndrome
- What is being tested?
- Pericostal Closure Technique and Intracostal Closure Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2013to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18-88 years age
- Patients undergoing surgery with an open thoracotomy incision
Who cannot join
- Patient refusal
- Inability to give informed consent
- Concurrent drug addiction or methadone use
- Present chronic pain syndrome
- Significant psychiatric illness excluding depression
- Cannot understand English, read or write in English independently
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques
Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.
- Conditions
- Post Thoracotomy Pain Syndrome
- Being tested
- Pericostal Closure Technique, Intracostal Closure Technique
- Keywords
- Neuropathic pain symptoms, Intracostal Closure Technique, Pericostal Suture Closure Technique, Post surgical pain, Post thoracotomy pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericostal Closure TechniqueProcedure or surgery
Intracostal Closure TechniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intracostal Closure Technique | Active comparator | Closure involves drilling four evenly spaced holes using a 5-mm bit attached to the end of a Stryker drill into the bed of the sixth rib. Receives: Procedure: Intracostal Closure Technique |
| Pericostal Closure Technique | Active comparator | Closure involves placing sutures around the ribs in the standard pericostal fashion Receives: Procedure: Pericostal Closure Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of post-thoracotomy pain
A Numerical Rating Score (NRS) for maximal daily pain from the patients surgical incision will also be measured (0 = no pain, 10 = worst possible pain) 3 months after surgery.
Measured: 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Thoracotomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hance Clarke, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898468
- Sponsor's protocol ID
- UHN13-5894
- Status last verified
- Oct 2018
- First submitted
- 2 Jul 2013
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Thoracotomy Pain Syndrome: A Randomized, Double Blind, Study Comparing Closure Techniques
- ClinicalTrials.gov ID
- NCT01898468
- Acronym / sponsor ID
- UHN13-5894
- Conditions
- Post Thoracotomy Pain Syndrome
- Keywords
- Neuropathic pain symptoms, Intracostal Closure Technique, Pericostal Suture Closure Technique, Post surgical pain, Post thoracotomy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 Jul 2013 (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.
Post-thoracotomy Pain Syndrome (PTPS) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." PTPS presents a frustrating challenge to patients and healthcare providers alike. PTPS can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. A proposed mechanism for PTPS is the compression of the intercostal nerves during routine closure. Closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. We propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. Participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. Our primary outcome will assess the incidence and severity of PTPS at 3, 6, and 12 months after surgery between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracostal Closure Technique | Active comparator | Procedure: Intracostal Closure TechniqueClosure involves drilling four evenly spaced holes using a 5-mm bit attached to the end of a Stryker drill into the bed of the sixth rib. |
| Pericostal Closure Technique | Active comparator | Procedure: Pericostal Closure TechniqueClosure involves placing sutures around the ribs in the standard pericostal fashion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18-88 years age
- Patients undergoing surgery with an open thoracotomy incision
Key exclusion criteria (6 listed)
- Patient refusal
- Inability to give informed consent
- Concurrent drug addiction or methadone use
- Present chronic pain syndrome
- Significant psychiatric illness excluding depression
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 Closure Technique | Procedure or surgery | Pericostal Closure Technique |
| Intracostal Closure Technique | Procedure or surgery | Intracostal Closure Technique |
Primary outcome
Incidence and severity of post-thoracotomy pain
Time frame: 3 months post surgery
A Numerical Rating Score (NRS) for maximal daily pain from the patients surgical incision will also be measured (0 = no pain, 10 = worst possible pain) 3 months after 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 8 Dec 2020.
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.
Hance Clarke, MD principal investigator
Toronto General Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericostal Closure Technique and Intracostal Closure Technique in people with Post Thoracotomy Pain Syndrome, run by University Health Network, Toronto at 2 sites in Canada.
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 6 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Incidence and severity of post-thoracotomy pain (time frame: 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2020.