Lung CancerNCT00653367
Evaluation of Chronic Pain After Nerve Section During Thoracotomy
A study testing Nerve section in people with Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nerve section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included for anterior or lateral thoracotomy
Who cannot join
- Unable to give consent due to age, cognitive reduction or otherwise
- Neurological disease or symptoms affection thoracic area
- Chronic pain prior to surgery
- Inability to supply the patient with an epidural catheter
- Pneumonectomy
- Prolonged infection at surgical site
- Invasive tumor growth
- Need for repeated surgery at site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Thoracotomy Pain After Nerve Section
The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.
- Conditions
- Lung Cancer
- Being tested
- Nerve section
- Keywords
- Thoracotomy, Nerve section, QST, Quantitative Sensory Test, Muscle sparing Posterolateral thoracotomy, Chest, Wall, Surgical, Incision, Tumors or cancer of the lung
- Medical subject headings
- Lung Neoplasms, Surgical Wound, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve sectionProcedure or surgery
Intercostal nerve is divided during surgery
| Study group | Role | What they receive |
|---|---|---|
| NS | Experimental | Nerve section of intercostal nerve during surgery Receives: Procedure: Nerve section |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (NRS)
Measured: 3 months postoperatively
Secondary outcomes (3)
QST parameters (sensory thresholds to cool/Warmth)
Measured: 3 months postoperatively
Social well-being (HADS / PCS)
Measured: 3 months postoperatively
Function (pain impairment of Activities of Daily Life)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startDec 2011
- Primary completionApr 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Kim Wildgaard, MD, Principal investigator, Section for Surgical Pathophysiology 4074Henrik Kehlet, MD, Phd, Pro, Study chair, Section for Surgical Pathophysiology 4074
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653367
- Sponsor's protocol ID
- RH-EKPF-2008-01
- Status last verified
- Aug 2011
- First submitted
- 1 Apr 2008
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Thoracotomy Pain After Nerve Section
- ClinicalTrials.gov ID
- NCT00653367
- Acronym / sponsor ID
- RH-EKPF-2008-01
- Conditions
- Lung Cancer
- Keywords
- Thoracotomy, Nerve section, QST, Quantitative Sensory Test, Muscle sparing Posterolateral thoracotomy, Chest, Wall, Surgical
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Apr 2008 (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 investigate if controlled nerve section reduces chronic pain after thoracotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS | Experimental | Procedure: Nerve sectionNerve section of intercostal nerve during surgery |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients included for anterior or lateral thoracotomy
Key exclusion criteria (8 listed)
- Unable to give consent due to age, cognitive reduction or otherwise
- Neurological disease or symptoms affection thoracic area
- Chronic pain prior to surgery
- Inability to supply the patient with an epidural catheter
- Pneumonectomy
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 |
|---|---|---|
| Nerve sectionIntercostal nerve is divided during surgery | Procedure or surgery | NS |
Primary outcome
Pain (NRS)
Time frame: 3 months postoperatively
3 secondary outcomes
QST parameters (sensory thresholds to cool/Warmth)
Time frame: 3 months postoperatively
Social well-being (HADS / PCS)
Time frame: 3 months postoperatively
Function (pain impairment of Activities of Daily Life)
Time frame: 3 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
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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.
Kim Wildgaard, MD principal investigator
Section for Surgical Pathophysiology 4074
Henrik Kehlet, MD, Phd, Pro study chair
Section for Surgical Pathophysiology 4074
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve section in people with Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Feb 2012. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain (NRS) (time frame: 3 months postoperatively). 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 24 Feb 2012.