Clinical trial NCT02230865: Prediction of Acute Postoperative Pain and Analgesic Consumption
Official title: Prediction of Acute Postoperative Pain and Analgesic Consumption by Preoperative Responses to Experimental Pain in Patients Undergoing Chest Wall Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Keywords: Funnel chest (Pectus excavatum)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 40
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with funnel chest (pectus excavatum) undergoing corrective chest wall surgery at Aarhus University Hospital

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Secondary exclusions included:

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

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: Within the first 5 days after surgery
measure: Postoperative pain unpleasantness
timeFrame: Within the first 5 days after surgery
measure: Postoperative consumption of analgesics
timeFrame: Within the first 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Deparment of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
Study officials:
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
name: Asbjørn M Drewes, MD, PhD, DMSci
role: STUDY_DIRECTOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
name: Kasper Grosen, MHSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
name: Hans K Pilegaard, MD
role: STUDY_CHAIR
affiliation: Department of Psychology, Aarhus University, Denmark
name: Lene Vase, MSc (Psychology), PhD
role: STUDY_CHAIR
affiliation: Aarhus University Hospital
name: Mogens Pfeiffer-Jensen, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
name: Vibeke E Hjortdal, MD, PhD, DMSci
role: STUDY_CHAIR
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
name: Anne E Olesen, PhD
role: STUDY_CHAIR
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
name: Mikkel Gram, MScEE
role: STUDY_CHAIR
References:
citation: 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.