Prediction of Acute Postoperative Pain and Analgesic Consumption

Postoperative Pain Clinical Trial

— MIRPEX-3  

Official title:

Prediction of Acute Postoperative Pain and Analgesic Consumption by Preoperative Responses to Experimental Pain in Patients Undergoing Chest Wall Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02230865
• Other study ID #: MIRPEX-3
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2014
• Last updated: May 29, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: University of Aarhus
• Contact: Kasper Grosen, MHSc, PhD
• Phone: 78464224
• Email: kasper.grosen[@]rm.dk
• Is FDA regulated: No
• Health authority: Denmark: The Central Denmark Region Committees on Health Research EthicsDenmark: Danish Data Protection Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Denmark	Deparment of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Kasper Grosen

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain intensity	11-point (0-10) numerical rating scale of pain intensity	Within the first 5 days after surgery	No
Primary	Postoperative pain unpleasantness	11-point (0-10) numerical rating scale of pain unpleasantness	Within the first 5 days after surgery	No
Primary	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	No

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