Postoperative PainMIRPEX-3NCT02230865
Prediction of Acute Postoperative Pain and Analgesic Consumption
An observational study of Postoperative Pain, run by Kasper Grosen at 1 site in Denmark.
Trial summary
Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Postoperative Pain
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Jun 2015
- 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 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with funnel chest (pectus excavatum) undergoing corrective chest wall surgery at Aarhus University Hospital
Who may be able to join
- Elective minimally invasive surgical correction of funnel chest (pectus excavatum
- age ≥15 years.
Who cannot join
- Previous thoracic surgical interventions
- Presence of diseases affecting the central and/or peripheral nervous system
- Presence of chronic pain conditions
- Inability to speak and/or understand Danish
- Inability to understand and participate in the experimental pain session
- Presence of psychiatric disorders
Show all 16Show fewer
- History of frostbite in the non-dominant upper limb
- Presence of sores or cuts on non-dominant upper limb
- Presence of cardiovascular disease
- History of fainting and/or seizures
- Presence of fractures of the non-dominant upper limb
- Presence of Reynaud's phenomenon.
- Secondary exclusions included:
- Insensitivity to experimental cold pressor pain
- Lack of epidural catheter placement
- Re-operation
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Deparment of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
Aarhus, 8200
About this study
Official title: Prediction of Acute Postoperative Pain and Analgesic Consumption by Preoperative Responses to Experimental Pain in Patients Undergoing Chest Wall Surgery
Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain.
We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.
Read the detailed description
Preselected preoperative predictor variables/individual patient characteristics include the following:
- Evoked brain potentials (using standard electroencephalographic brain imaging)
- Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)
- Pressure pain detection and tolerance thresholds in muscle (m.quadriceps)
- Pressure pain tolerance thresholds in bone (sternum and tibia)
- Heat pain tolerance threshold in skin (forearm)
- Responses to the Situational and Dispositional Pain Catastrophizing Scale
- Response to the State-Trait and Anxiety Inventory
- Response to the Beck's Depression Inventory
- Conditions
- Postoperative Pain
- Keywords
- Funnel chest (Pectus excavatum)
- Medical subject headings
- Pain, Postoperative, Funnel Chest
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 |
|---|---|---|
| Surgery | Minimally invasive repair of pectus excavatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
11-point (0-10) numerical rating scale of pain intensity
Measured: Within the first 5 days after surgery
Postoperative pain unpleasantness
11-point (0-10) numerical rating scale of pain unpleasantness
Measured: Within the first 5 days after surgery
Postoperative consumption of analgesics
The use of all pain-related treatments, including rescue analgesics and any other concomitant pain treatments.
Measured: Within the first 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasper Grosen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kasper Grosen, Aarhus University Hospital
- Investigators
- Asbjørn M Drewes, MD, PhD, DMSci, Study director, Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, DenmarkKasper Grosen, MHSc, PhD, Principal investigator, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, DenmarkHans K Pilegaard, MD, Study chair, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, DenmarkLene Vase, MSc (Psychology), PhD, Study chair, Department of Psychology, Aarhus University, DenmarkMogens Pfeiffer-Jensen, MD, PhD, Study chair, Aarhus University HospitalVibeke E Hjortdal, MD, PhD, DMSci, Study chair, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, DenmarkAnne E Olesen, PhD, Study chair, Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, DenmarkMikkel Gram, MScEE, Study chair, Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230865
- Sponsor's protocol ID
- MIRPEX-3
- Acronym
- MIRPEX-3
- Status last verified
- May 2015
- First submitted
- 29 Aug 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Grosen K, Vase L, Pilegaard HK, Pfeiffer-Jensen M, Drewes AM. Conditioned pain modulation and situational pain catastrophizing as preoperative predictors of pain following chest wall surgery: a prospective observational cohort study. PLoS One. 2014 Feb 26;9(2):e90185. doi: 10.1371/journal.pone.0090185. eCollection 2014.
PubMed 24587268
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Acute Postoperative Pain and Analgesic Consumption by Preoperative Responses to Experimental Pain in Patients Undergoing Chest Wall Surgery
- ClinicalTrials.gov ID
- NCT02230865
- Acronym / sponsor ID
- MIRPEX-3 / MIRPEX-3
- Conditions
- Postoperative Pain
- Keywords
- Funnel chest (Pectus excavatum)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kasper GrosenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 3 Sep 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.
Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain.
We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.
Detailed description
Preselected preoperative predictor variables/individual patient characteristics include the following:
- Evoked brain potentials (using standard electroencephalographic brain imaging)
- Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)
- Pressure pain detection and tolerance thresholds in muscle (m.quadriceps)
- Pressure pain tolerance thresholds in bone (sternum and tibia)
- Heat pain tolerance threshold in skin (forearm)
- Responses to the Situational and Dispositional Pain Catastrophizing Scale
- Response to the State-Trait and Anxiety Inventory
- Response to the Beck's Depression Inventory
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | –Minimally invasive repair of pectus excavatum |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with funnel chest (pectus excavatum) undergoing corrective chest wall surgery at Aarhus University Hospital
Key inclusion criteria (2 listed)
- Elective minimally invasive surgical correction of funnel chest (pectus excavatum
- age ≥15 years.
Key exclusion criteria (16 listed)
- Previous thoracic surgical interventions
- Presence of diseases affecting the central and/or peripheral nervous system
- Presence of chronic pain conditions
- Inability to speak and/or understand Danish
- Inability to understand and participate in the experimental pain session
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
Postoperative pain intensity
Time frame: Within the first 5 days after surgery
11-point (0-10) numerical rating scale of pain intensity
Postoperative pain unpleasantness
Time frame: Within the first 5 days after surgery
11-point (0-10) numerical rating scale of pain unpleasantness
Postoperative consumption of analgesics
Time frame: Within the first 5 days after surgery
The use of all pain-related treatments, including rescue analgesics and any other concomitant pain treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Background: PubMed 24587268Grosen K, Vase L, Pilegaard HK, Pfeiffer-Jensen M, Drewes AM. Conditioned pain modulation and situational pain catastrophizing as preoperative predictors of pain following chest wall surgery: a prospective observational cohort study. PLoS One. 2014 Feb 26;9(2):e90185. doi: 10.1371/journal.pone.0090185. eCollection 2014.
- Related InfoLink provided by the sponsor.
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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.
Asbjørn M Drewes, MD, PhD, DMSci study director
Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
Kasper Grosen, MHSc, PhD principal investigator
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
Hans K Pilegaard, MD study chair
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
1 site 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, run by Kasper Grosen 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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 1 Jun 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kasper Grosen, MHSc, PhD (78464224, kasper.grosen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: Within the first 5 days after surgery). The study lists 3 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 NCT02230865, which also lists 1 linked publication.
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 1 Jun 2015.