Prediction of Acute Postoperative Pain and Analgesic Consumption

NCT02230865 | Unknown

• 1 other identifier: MIRPEX-3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain

Keywords

Funnel chest (Pectus excavatum)

Outcome Measures

Primary Outcomes (3)

• Postoperative pain intensity

  11-point (0-10) numerical rating scale of pain intensity

  Within the first 5 days after surgery

• Postoperative pain unpleasantness

  11-point (0-10) numerical rating scale of pain unpleasantness

  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.

  Within the first 5 days after surgery

Study Arms (1)

Surgery

Minimally invasive repair of pectus excavatum

Eligibility Criteria

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

Study Population

Patients with funnel chest (pectus excavatum) undergoing corrective chest wall surgery at Aarhus University Hospital

You may qualify if:

• Elective minimally invasive surgical correction of funnel chest (pectus excavatum
• age ≥15 years.

You may not qualify if:

• 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
• 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.
• Insensitivity to experimental cold pressor pain
• Lack of epidural catheter placement
• Re-operation

Sponsors & Collaborators

• Kasper Grosen: lead

Study Sites (1)

Deparment of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark

Aarhus, 8200, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 24587268 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative; Funnel Chest

Condition Hierarchy (Ancestors)

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

Study Officials

• Asbjørn M Drewes, MD, PhD, DMSci

  Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark

  STUDY DIRECTOR

• Kasper Grosen, MHSc, PhD

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

  PRINCIPAL INVESTIGATOR

• Hans K Pilegaard, MD

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

  STUDY CHAIR

• Lene Vase, MSc (Psychology), PhD

  Department of Psychology, Aarhus University, Denmark

  STUDY CHAIR

• Mogens Pfeiffer-Jensen, MD, PhD

  Aarhus University Hospital

  STUDY CHAIR

• Vibeke E Hjortdal, MD, PhD, DMSci

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

  STUDY CHAIR

• Anne E Olesen, PhD

  Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark

  STUDY CHAIR

• Mikkel Gram, MScEE

  Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark

  STUDY CHAIR

Central Study Contacts

Kasper Grosen, MHSc, PhD

CONTACT

78464224; kasper.grosen@rm.dk

Asbjørn M Drewes, MD, PhD, DMSci

CONTACT

97660000; amd@rn.dk

Study Design

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

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 1, 2015

Record last verified: 2015-05

Locations

DK (1)