Prediction and Characterization of Acute and Chronic Postoperative Pain

NCT01308385 | Completed

• 1 other identifier: MIRPEX-2
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain; Pain, Postoperative; Funnel Chest

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months postoperatively

Secondary Outcomes (24)

• Pain intensity at rest

  Daily for up to 42 days postoperatively, at 6 months follow-up

• Pain intensity when active

  Daily for up to 42 days postoperatively, at 6 months follow-up

• Pain unpleasantness/discomfort at rest

  Daily for up to 42 days postoperatively, at 6 months follow-up

• Pain unpleasantness/discomfort when active

  Daily for up to 42 days postoperatively, at 6 months follow-up

• Pain location

  Daily for up to 42 days postoperatively, at 6 months follow-up

Study Arms (1)

Patients with pectus excavatum

Other: Conditioned pain modulation

Interventions

Conditioned pain modulation OTHER

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.

Patients with pectus excavatum

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elective consequtive patients admitted for surgical correction of pectus excavatum

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Cardiothoracic and Vascular Surgery

Aarhus, DK-8200, Denmark

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Funnel Chest

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lene Vase, Cand.psyc, PhD

  University of Aarhus

  STUDY CHAIR

• Mogens Pfeiffer-Jensen, MD, PhD

  Department of Rheumatology, Aarhus University Hospital

  STUDY CHAIR

• Hans K Pilegaard, MD

  Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• Kasper Grosen, PhD Student

  Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

DK (1)