Postoperative PainNCT00719368
Neurophysiological Characterization of Postherniotomy Pain
An observational study of Postoperative Pain and Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postherniotomy Pain, Neuropathic Pain
- How many people
- 48 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2006to Sep 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: persistent posthenriotomy patients
Who may be able to join
- Male patients >18 yrs
- Inguinal herniotomy >1 yr previously
- No sign of hernia recurrence
- Unilateral chronic groin pain lasting more than 3 months
- Moderate/severe pain related impairment of everyday activities.
Who cannot join
- Other causes of persistent pain in groin region (hip, other surgical procedures)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Pain Research Centre
Aarhus, 8000
Section for Surgical Pathophysiology
Copenhagen, 2100
About this study
Official title: Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients
Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.
- Conditions
- Postoperative Pain, Postherniotomy Pain, Neuropathic Pain
- Keywords
- Groin hernia, pain, chronic, quantitative sensory testing, Persistent postoperative pain
- Medical subject headings
- Pain, Postoperative, Neuralgia, Hernia, Inguinal, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pain-free control | Pain-free controls from previous prospective study (KF 01294867), operated >2 years previously | |
| Pain Patients | Patients with persistent postherniotomy pain lasting >1 year and pain related impaired daily function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory function
Measured: actual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, M.D., Study director, Rigshospitalet, Copenhagen University, DenmarkHenrik Kehlet, M.D., Ph. D., Principal investigator, Rigshospitalet, Copenhagen University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719368
- Sponsor's protocol ID
- KF 01267755
- Status last verified
- Oct 2012
- First submitted
- 17 Jul 2008
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Kehlet H. Neurophysiological characterization of postherniotomy pain. Pain. 2008 Jul;137(1):173-181. doi: 10.1016/j.pain.2007.09.026. Epub 2007 Oct 31.
PubMed 17976914Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.
PubMed 15531621
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients
- ClinicalTrials.gov ID
- NCT00719368
- Acronym / sponsor ID
- KF 01267755
- Conditions
- Postoperative Pain, Postherniotomy Pain, Neuropathic Pain
- Keywords
- Groin hernia, pain, chronic, quantitative sensory testing, Persistent postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jul 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.
Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain-free control | – | –Pain-free controls from previous prospective study (KF 01294867), operated >2 years previously |
| Pain Patients | – | –Patients with persistent postherniotomy pain lasting >1 year and pain related impaired daily function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- persistent posthenriotomy patients
Key inclusion criteria (5 listed)
- Male patients >18 yrs
- Inguinal herniotomy >1 yr previously
- No sign of hernia recurrence
- Unilateral chronic groin pain lasting more than 3 months
- Moderate/severe pain related impairment of everyday activities.
Key exclusion criteria (1 listed)
- Other causes of persistent pain in groin region (hip, other surgical procedures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory function
Time frame: actual
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 7 Apr 2014.
- Background: PubMed 17976914Aasvang EK, Brandsborg B, Christensen B, Jensen TS, Kehlet H. Neurophysiological characterization of postherniotomy pain. Pain. 2008 Jul;137(1):173-181. doi: 10.1016/j.pain.2007.09.026. Epub 2007 Oct 31.
- Background: PubMed 15531621Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.
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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.
Eske K Aasvang, M.D. study director
Rigshospitalet, Copenhagen University, Denmark
Henrik Kehlet, M.D., Ph. D. principal investigator
Rigshospitalet, Copenhagen University, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 5 inclusion and 1 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 7 Apr 2014. 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 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 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?
Sensory function (time frame: actual). 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 NCT00719368, which also lists 2 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 7 Apr 2014.