Prediction and Characterization of Acute and Chronic Postoperative Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01308385
First received: March 3, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention
Pain
Pain, Postoperative
Funnel Chest
Other: Conditioned pain modulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Persistent postoperative pain [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain intensity at rest [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"

  • Pain intensity when active [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"

  • Pain unpleasantness/discomfort at rest [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    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"

  • Pain unpleasantness/discomfort when active [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    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"

  • Pain location [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    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.

  • Postoperative usage of analgesics [ Time Frame: Daily for up to 42 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Usage of analgesics is divided into non-opioid and opioid analgesics and into prescribed and as needed usage.

  • Postoperative usage epidural analgesia [ Time Frame: Within 4 days postoperatively ] [ Designated as safety issue: No ]
    Usage of epidural analgesia is measured as both total and bolus infusion of epidural analgesics i millilitres (Ml)

  • Intensity of brush-evoked pain (mechanical allodynia) [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    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"

  • Intensity of brush-evoked discomfort (mechanical allodynia) [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    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"

  • Dysaesthesia [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    Presence of dysaesthesia when stroking the skin on the thorax with a brush

  • Intensity of pinprick-evoked pain (mechanical dynamical hyperalgesia) [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    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"

  • Hypoalgesia (skin) [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    Presence of hypoalgesia on the thorax is defined as a reduced response to pinprick (Von Frey)

  • Peri-incisional secondary hyperalgesia [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    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

  • Generalized secondary hyperalgesia [ Time Frame: At 6 weeks follow-up ] [ Designated as safety issue: No ]
    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

  • Personality [ Time Frame: At 6 months follow-up ] [ Designated as safety issue: No ]
    Response to Neuroticism, extraversion, openness, personality inventory - revised (NEO-PI-R) at 6 months follow-up compared to baseline

  • Pain Catastrophizing [ Time Frame: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Pain Catastrophizing Scale (PCS) compared to baseline

  • Anxiety [ Time Frame: At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the State-Trait Anxiety Inventory (STAI) compared to baseline

  • Depression [ Time Frame: At baseline, at 3 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Beck's depression Inventory - second edition (BPI-II) compared to baseline

  • Emotions [ Time Frame: At baseline, at 3 days postoperatively, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Positive and Negative Affective Scale (PANAS) compared to baseline

  • Health-related Quality of life [ Time Frame: At baseline, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Short Form Health Survey (SF-36) compared to baseline

  • Self-esteem [ Time Frame: At baseline, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Rosenberg Self-esteem Scale (SES) compared to baseline

  • 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 ] [ Designated as safety issue: No ]
    Responses to the McGill Pain Questionnaire - short form (SF-MPQ) compared to baseline

  • Pain interference with daily life [ Time Frame: At baseline, at 6 weeks follow-up, at 6 months follow-up ] [ Designated as safety issue: No ]
    Responses to the Brief Pain Inventory - short form (SF-BPI) compared to baseline

  • Course of pain [ Time Frame: At 6 weeks follow-up, at 6 months follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with pectus excavatum Other: Conditioned pain modulation
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Elective consequtive patients admitted for surgical correction of pectus excavatum

Criteria

Inclusion Criteria:

  • Patients undergoing minimally invasive repair of pectus excavatum
  • Age > 15 years old

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308385

Locations
Denmark
Department of Cardiothoracic and Vascular Surgery
Aarhus, Denmark, DK-8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Lene Vase, Cand.psyc, PhD Department of Psychology, Aarhus University
Study Chair: Mogens Pfeiffer-Jensen, MD, PhD Department of Rheumatology, Aarhus University Hospital
Study Director: Hans K Pilegaard, MD Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Study Chair: Asbjørn M Drewes, Prof., MD, PhD, DMsc Mech-Sense, Department of Gastroenterology, Aarhus University Hospital, Aalborg Hospital,
Study Chair: Vibeke E Hjortdal, Prof., MD, PhD, DMSc Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
Principal Investigator: Kasper Grosen, PhD Student Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01308385     History of Changes
Other Study ID Numbers: MIRPEX-2
Study First Received: March 3, 2011
Last Updated: September 12, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Funnel Chest
Pain, Postoperative
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014