PainNCT01308385
Prediction and Characterization of Acute and Chronic Postoperative Pain
An observational study of Pain and Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
Trial summary
Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pain, Pain, Postoperative, Funnel Chest
- What is being tested?
- Conditioned pain modulation
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Oct 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Elective consequtive patients admitted for surgical correction of pectus excavatum
Who may be able to join
- Patients undergoing minimally invasive repair of pectus excavatum
- Age > 15 years old
Who cannot join
- Previous thoracic surgery interventions
- Disorders affecting the central or peripheral nervous system
- Chronic pain (pain intensity assessed by numerical rating scale > 3)
- Inability to speak and understand Danish (instructions, questionnaires)
- Inability to understand and participate in experimental pain modulation
- Psychiatric disorders (ICD-10)
Show all 12Show fewer
- A history of frostbite in the non-dominant upper limb
- Sores or cuts on non-dominant upper limb
- Cardiovascular disease
- A history of fainting and/or seizures
- Fracture in non-dominant upper limb
- Reynaud's phenomenon
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic and Vascular Surgery
Aarhus, DK-8200
About this study
Official title: Prediction and Characterization of Acute and Chronic Postoperative Pain - a Longitudinal Observational Study of the Relationship Between Experimental Pain Modulation and Clinical Postoperative Pain in Patients Undergoing Minimally Invasive Repair of Pectus Excavatum
Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress.
Conditioned Pain Modulation (CPM), also known as the phenomenon "pain-inhibits-pain", is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions.
Read more
The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain.
Hypothesis:
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain.
Secondary hypotheses
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative period.
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the shorter duration of early postoperative pain.
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).
- The larger the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).
- Severe acute pain in the early postoperative period (postoperative days 0-3) is positively associated with the development of persistent postoperative pain (6 months postoperatively).
- Presence of preoperative pain and / or high postoperative use of analgesics and / or high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months postoperatively.
- The higher pain intensity and discomfort associated with brush-evoked allodynia and / or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing persistent postoperative pain (6 months postoperatively).
- High levels of preoperative catastrophizing (assessed on the day of admission) is related to the severity of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively), even if controlled for depression and anxiety.
- The degree of preoperative positive and negative emotions (as assessed on the day of admission) is related to the degree of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively) so that negative emotions are associated with high levels of pain, while positive feelings are related to low levels of pain.
- The study population does not differ significantly from the normal population in terms of personality traits (emotional reactions, extraversion, openness to experience, friendliness, conscientiousness).
- The study population does not experience a significant change in personality traits during the first 6 months after surgery.
- The quality of life and self-esteem is lower among patients who develop persistent postoperative pain compared with pain patients.
- Quality of life and self-esteem improve as a result of minimally invasive repair of pectus excavatum.
- Conditions
- Pain, Pain, Postoperative, Funnel Chest
- Being tested
- Conditioned pain modulation
- Medical subject headings
- Pain, Pain, Postoperative, Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned pain modulationOther
When evaluating conditioned pain modulation, pressure pain threshold in the musculus quadriceps femoris act as test stimulus and 2 minutes cold pressor test (stirred ice and water) acts as the conditioning stimulus. The difference between pain thresholds before and after the cold pressor test is defined as the effect of CPM.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pectus excavatum | Not described Receives: Other: Conditioned pain modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent postoperative pain
Pain that develops and persists after minimally invasive repair of pectus excavatum. Other causes of pain (e.g. infection) and preoperatively defined painful conditions are are excluded.
Measured: 6 months postoperatively
Secondary outcomes (24)
Pain intensity at rest
Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain intensity when active
Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain unpleasantness/discomfort at rest
Pain unpleasantness/discomfort is measured by means of an 11-point numerical rating scale with the verbal anchors "No unpleasantness/discomfort" and "Worst unpleasantness/discomfort imaginable"
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain unpleasantness/discomfort when active
Pain unpleasantness/discomfort is measured by means of an 11-point numerical rating scale with the verbal anchors "No unpleasantness/discomfort" and "Worst unpleasantness/discomfort imaginable"
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain location
Painful areas are marked on a figure illustrating a human torso (both front and back are shown). The figure has predefined squares in order to standardize report.
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Postoperative usage of analgesics
Usage of analgesics is divided into non-opioid and opioid analgesics and into prescribed and as needed usage.
Measured: Daily for up to 42 days postoperatively, at 6 months follow-up
Postoperative usage epidural analgesia
Usage of epidural analgesia is measured as both total and bolus infusion of epidural analgesics i millilitres (Ml)
Measured: Within 4 days postoperatively
Intensity of brush-evoked pain (mechanical allodynia)
Any pain evoked by brush on the thorax (mechanical allodynia) is rated on 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"
Measured: At 6 weeks follow-up
Intensity of brush-evoked discomfort (mechanical allodynia)
Any discomfort evoked by brush on the thorax (mechanical allodynia) is rated on 11-point numerical rating scale with the verbal anchors "No discomfort" and "Worst discomfort imaginable"
Measured: At 6 weeks follow-up
Dysaesthesia
Presence of dysaesthesia when stroking the skin on the thorax with a brush
Measured: At 6 weeks follow-up
Intensity of pinprick-evoked pain (mechanical dynamical hyperalgesia)
Any pain evoked by pinprick (Von Frey) on the thorax (mechanical dynamical hyperalgesia) is rated on 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"
Measured: At 6 weeks follow-up
Hypoalgesia (skin)
Presence of hypoalgesia on the thorax is defined as a reduced response to pinprick (Von Frey)
Measured: At 6 weeks follow-up
Peri-incisional secondary hyperalgesia
Negative difference between pressure pain thresholds (skinfold pinch) measured before surgery and at 6 weeks follow-up. Meassurements are made with a handheld pressure algometer 5 cm distal to the papilla
Measured: At 6 weeks follow-up
Generalized secondary hyperalgesia
Negative difference between pressure pain thresholds (musculus quadriceps femoris) measured before surgery and at 6 weeks follow-up. Meassurements are made with a handheld pressure algometer in the quadriceps 10 cm above to the patella
Measured: At 6 weeks follow-up
Personality
Response to Neuroticism, extraversion, openness, personality inventory - revised (NEO-PI-R) at 6 months follow-up compared to baseline
Measured: At 6 months follow-up
Pain Catastrophizing
Responses to the Pain Catastrophizing Scale (PCS) compared to baseline
Measured: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up
Anxiety
Responses to the State-Trait Anxiety Inventory (STAI) compared to baseline
Measured: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up
Depression
Responses to the Beck's depression Inventory - second edition (BPI-II) compared to baseline
Measured: At baseline, at 3 days postoperatively, at 6 months follow-up
Emotions
Responses to the Positive and Negative Affective Scale (PANAS) compared to baseline
Measured: At baseline, at 3 days postoperatively, at 6 months follow-up
Health-related Quality of life
Responses to the Short Form Health Survey (SF-36) compared to baseline
Measured: At baseline, at 6 months follow-up
Self-esteem
Responses to the Rosenberg Self-esteem Scale (SES) compared to baseline
Measured: At baseline, at 6 months follow-up
Qualitative dimension of pain
Responses to the McGill Pain Questionnaire - short form (SF-MPQ) compared to baseline
Measured: At baseline, following coldpressor test, at 3 days postoperatively, at 6 weeks follow-up, at 6 months follow-up
Pain interference with daily life
Responses to the Brief Pain Inventory - short form (SF-BPI) compared to baseline
Measured: At baseline, at 6 weeks follow-up, at 6 months follow-up
Course of pain
Course of pain is defined as 1.) constant pain with few fluctuations, 2.) constant pain with breakthrough pain, 3.) Breakthrough pain without pain in between, 4.) Breakthrough pain with pain in between.
Measured: At 6 weeks follow-up, at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
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 University of AarhusThe 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
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Vase, Cand.psyc, PhD, Study chair, University of AarhusMogens Pfeiffer-Jensen, MD, PhD, Study chair, Department of Rheumatology, Aarhus University HospitalHans K Pilegaard, MD, Study director, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, SkejbyAsbjørn M Drewes, Prof., MD, PhD, DMsc, Study chair, Mech-Sense, Department of Gastroenterology, Aarhus University Hospital, Aalborg Hospital,Vibeke E Hjortdal, Prof., MD, PhD, DMSc, Study chair, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, SkejbyKasper Grosen, PhD Student, Principal investigator, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308385
- Sponsor's protocol ID
- MIRPEX-2
- Status last verified
- Aug 2014
- First submitted
- 3 Mar 2011
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Characterization of Acute and Chronic Postoperative Pain - a Longitudinal Observational Study of the Relationship Between Experimental Pain Modulation and Clinical Postoperative Pain in Patients Undergoing Minimally Invasive Repair of Pectus Excavatum
- ClinicalTrials.gov ID
- NCT01308385
- Acronym / sponsor ID
- MIRPEX-2
- Conditions
- Pain, Pain, Postoperative, Funnel Chest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Mar 2011 (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.
Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress.
Conditioned Pain Modulation (CPM), also known as the phenomenon "pain-inhibits-pain", is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions.
The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain.
Hypothesis:
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain.
Secondary hypotheses
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative period.
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the shorter duration of early postoperative pain.
- The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml).
- The larger the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day).
- Severe acute pain in the early postoperative period (postoperative days 0-3) is positively associated with the development of persistent postoperative pain (6 months postoperatively).
- Presence of preoperative pain and / or high postoperative use of analgesics and / or high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months postoperatively.
- The higher pain intensity and discomfort associated with brush-evoked allodynia and / or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing persistent postoperative pain (6 months postoperatively).
- High levels of preoperative catastrophizing (assessed on the day of admission) is related to the severity of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively), even if controlled for depression and anxiety.
- The degree of preoperative positive and negative emotions (as assessed on the day of admission) is related to the degree of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively) so that negative emotions are associated with high levels of pain, while positive feelings are related to low levels of pain.
- The study population does not differ significantly from the normal population in terms of personality traits (emotional reactions, extraversion, openness to experience, friendliness, conscientiousness).
- The study population does not experience a significant change in personality traits during the first 6 months after surgery.
- The quality of life and self-esteem is lower among patients who develop persistent postoperative pain compared with pain patients.
- Quality of life and self-esteem improve as a result of minimally invasive repair of pectus excavatum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pectus excavatum | – | Other: Conditioned pain modulation |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elective consequtive patients admitted for surgical correction of pectus excavatum
Key inclusion criteria (2 listed)
- Patients undergoing minimally invasive repair of pectus excavatum
- Age > 15 years old
Key exclusion criteria (12 listed)
- Previous thoracic surgery interventions
- Disorders affecting the central or peripheral nervous system
- Chronic pain (pain intensity assessed by numerical rating scale > 3)
- Inability to speak and understand Danish (instructions, questionnaires)
- Inability to understand and participate in experimental pain modulation
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 |
|---|---|---|
| Conditioned pain modulationWhen evaluating conditioned pain modulation, pressure pain threshold in the musculus quadriceps femoris act as test stimulus and 2 minutes cold pressor test (stirred ice and water) acts as the conditioning stimulus. The difference between pain thresholds before and after the cold pressor test is defined as the effect of CPM. | Other | Patients with pectus excavatum |
Primary outcome
Persistent postoperative pain
Time frame: 6 months postoperatively
Pain that develops and persists after minimally invasive repair of pectus excavatum. Other causes of pain (e.g. infection) and preoperatively defined painful conditions are are excluded.
24 secondary outcomes
Pain intensity at rest
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain intensity when active
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain unpleasantness/discomfort at rest
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain unpleasantness/discomfort when active
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Pain location
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Postoperative usage of analgesics
Time frame: Daily for up to 42 days postoperatively, at 6 months follow-up
Postoperative usage epidural analgesia
Time frame: Within 4 days postoperatively
Intensity of brush-evoked pain (mechanical allodynia)
Time frame: At 6 weeks follow-up
Intensity of brush-evoked discomfort (mechanical allodynia)
Time frame: At 6 weeks follow-up
Dysaesthesia
Time frame: At 6 weeks follow-up
Intensity of pinprick-evoked pain (mechanical dynamical hyperalgesia)
Time frame: At 6 weeks follow-up
Hypoalgesia (skin)
Time frame: At 6 weeks follow-up
Peri-incisional secondary hyperalgesia
Time frame: At 6 weeks follow-up
Generalized secondary hyperalgesia
Time frame: At 6 weeks follow-up
Personality
Time frame: At 6 months follow-up
Pain Catastrophizing
Time frame: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up
Anxiety
Time frame: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up
Depression
Time frame: At baseline, at 3 days postoperatively, at 6 months follow-up
Emotions
Time frame: At baseline, at 3 days postoperatively, at 6 months follow-up
Health-related Quality of life
Time frame: At baseline, at 6 months follow-up
Self-esteem
Time frame: At baseline, at 6 months follow-up
Qualitative dimension of pain
Time frame: At baseline, following coldpressor test, at 3 days postoperatively, at 6 weeks follow-up, at 6 months follow-up
Pain interference with daily life
Time frame: At baseline, at 6 weeks follow-up, at 6 months follow-up
Course of pain
Time frame: At 6 weeks follow-up, at 6 months follow-up
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 Aug 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.
Lene Vase, Cand.psyc, PhD study chair
University of Aarhus
Mogens Pfeiffer-Jensen, MD, PhD study chair
Department of Rheumatology, Aarhus University Hospital
Hans K Pilegaard, MD study director
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
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 Pain and Pain, Postoperative, run by University of Aarhus 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 12 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 Aug 2014. 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 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?
Persistent postoperative pain (time frame: 6 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 8 Aug 2014.