PainNCT01546480
From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
An observational study of Pain, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation. The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 18 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2011to Feb 2014
- 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: Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain. Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.
Who may be able to join
- Unexplained abdominal pain 12 months after elective cholecystectomy
- No pain 12 months after elective cholecystectomy
- Elective operation in spinal anesthesia or
- Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected
Who cannot join
- Immunosuppressive treatment (NSAID excepted)
- Anticoagulant treatment
- Group 2:
- Immunosuppressive treatment (NSAID excepted)
- Anticoagulant treatment
- Group 3:
Show all 9Show fewer
- Acute or chronic pain condition
- Immunosuppressive treatment (NSAID excepted)
- Previous abdominal operation
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Odense University Hospital
Odense, 5000
Lillebælt Hospital
Vejle, 7100
About this study
Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.
The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.
DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.
- Conditions
- Pain
- Keywords
- Chronic postoperative pain, Postcholecystectomy pain, Inflammation, Interleukines
- Medical subject headings
- Pain, Pain, Postoperative, Inflammation
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 patients | Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy | |
| Operated painfree Patients | Painfree patients 12 months after elective cholecystectomy | |
| Nonoperated painfree patients | Painfree patients with no previous abdominal operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal interleukine levels
12 months after surgery
Measured: 12 months
Secondary outcomes (3)
Blood interleukine levels
Measured: 12 Months
spinal enzyme levels
12 months after surgery
Measured: 12 months
Blood enzyme levels
12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Oberstinde Kirsten Jensa la Cours Foundation
- Responsible party
- Principal investigator, Morten Rune Eckhardt, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546480
- Sponsor's protocol ID
- ImmT
- Other IDs
- 119
- Status last verified
- Jun 2014
- First submitted
- 2 Mar 2012
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
- ClinicalTrials.gov ID
- NCT01546480
- Acronym / sponsor ID
- ImmT
- Conditions
- Pain
- Keywords
- Chronic postoperative pain, Postcholecystectomy pain, Inflammation, Interleukines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Vejle Hospital, Oberstinde Kirsten Jensa la Cours Foundation
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Mar 2012 (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.
Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.
The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.
DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain patients | – | –Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy |
| Operated painfree Patients | – | –Painfree patients 12 months after elective cholecystectomy |
| Nonoperated painfree patients | – | –Painfree patients with no previous abdominal operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain. Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.
Key inclusion criteria (4 listed)
- Unexplained abdominal pain 12 months after elective cholecystectomy
- No pain 12 months after elective cholecystectomy
- Elective operation in spinal anesthesia or
- Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected
Key exclusion criteria (9 listed)
- Immunosuppressive treatment (NSAID excepted)
- Anticoagulant treatment
- Immunosuppressive treatment (NSAID excepted)
- Anticoagulant treatment
- Acute or chronic pain condition
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
Spinal interleukine levels
Time frame: 12 months
12 months after surgery
3 secondary outcomes
Blood interleukine levels
Time frame: 12 Months
spinal enzyme levels
Time frame: 12 months
Blood enzyme levels
Time frame: 12 months
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 17 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pain, run by Odense University Hospital 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 4 inclusion and 9 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 17 Jun 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?
Spinal interleukine levels (time frame: 12 months). 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 17 Jun 2014.