Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02230865
Other study ID # MIRPEX-3
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A

External Links