Prediction and Characterization of Acute and Chronic Postoperative Pain

Pain Clinical Trial

Official title:

Prediction and Characterization of Acute and Chronic Postoperative Pain - a Longitudinal Observational Study of the Relationship Between Experimental Pain Modulation and Clinical Postoperative Pain in Patients Undergoing Minimally Invasive Repair of Pectus Excavatum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308385
• Other study ID #: MIRPEX-2
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: August 7, 2014
• Start date: April 2011
• Est. completion date: October 2012

Study information

• Verified date: August 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing minimally invasive repair of pectus excavatum

• Age > 15 years old

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Funnel Chest
• Pain
• Pain, Postoperative

Intervention

Other:
• Conditioned pain modulation
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.

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic and Vascular Surgery	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain intensity at rest	Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Pain intensity when active	Pain intensity is measured by means of an 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Pain unpleasantness/discomfort at rest	Pain unpleasantness/discomfort is measured by means of an 11-point numerical rating scale with the verbal anchors "No unpleasantness/discomfort" and "Worst unpleasantness/discomfort imaginable"	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Pain unpleasantness/discomfort when active	Pain unpleasantness/discomfort is measured by means of an 11-point numerical rating scale with the verbal anchors "No unpleasantness/discomfort" and "Worst unpleasantness/discomfort imaginable"	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Pain location	Painful areas are marked on a figure illustrating a human torso (both front and back are shown). The figure has predefined squares in order to standardize report.	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Postoperative usage of analgesics	Usage of analgesics is divided into non-opioid and opioid analgesics and into prescribed and as needed usage.	Daily for up to 42 days postoperatively, at 6 months follow-up	No
Secondary	Postoperative usage epidural analgesia	Usage of epidural analgesia is measured as both total and bolus infusion of epidural analgesics i millilitres (Ml)	Within 4 days postoperatively	No
Secondary	Intensity of brush-evoked pain (mechanical allodynia)	Any pain evoked by brush on the thorax (mechanical allodynia) is rated on 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"	At 6 weeks follow-up	No
Secondary	Intensity of brush-evoked discomfort (mechanical allodynia)	Any discomfort evoked by brush on the thorax (mechanical allodynia) is rated on 11-point numerical rating scale with the verbal anchors "No discomfort" and "Worst discomfort imaginable"	At 6 weeks follow-up	No
Secondary	Dysaesthesia	Presence of dysaesthesia when stroking the skin on the thorax with a brush	At 6 weeks follow-up	No
Secondary	Intensity of pinprick-evoked pain (mechanical dynamical hyperalgesia)	Any pain evoked by pinprick (Von Frey) on the thorax (mechanical dynamical hyperalgesia) is rated on 11-point numerical rating scale with the verbal anchors "No pain" and "Worst pain imaginable"	At 6 weeks follow-up	No
Secondary	Hypoalgesia (skin)	Presence of hypoalgesia on the thorax is defined as a reduced response to pinprick (Von Frey)	At 6 weeks follow-up	No
Secondary	Peri-incisional secondary hyperalgesia	Negative difference between pressure pain thresholds (skinfold pinch) measured before surgery and at 6 weeks follow-up. Meassurements are made with a handheld pressure algometer 5 cm distal to the papilla	At 6 weeks follow-up	No
Secondary	Generalized secondary hyperalgesia	Negative difference between pressure pain thresholds (musculus quadriceps femoris) measured before surgery and at 6 weeks follow-up. Meassurements are made with a handheld pressure algometer in the quadriceps 10 cm above to the patella	At 6 weeks follow-up	No
Secondary	Personality	Response to Neuroticism, extraversion, openness, personality inventory - revised (NEO-PI-R) at 6 months follow-up compared to baseline	At 6 months follow-up	No
Secondary	Pain Catastrophizing	Responses to the Pain Catastrophizing Scale (PCS) compared to baseline	At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up	No
Secondary	Anxiety	Responses to the State-Trait Anxiety Inventory (STAI) compared to baseline	At baseline, following coldpressor test, at 3 days postoperatively, at 6 months follow-up	No
Secondary	Depression	Responses to the Beck's depression Inventory - second edition (BPI-II) compared to baseline	At baseline, at 3 days postoperatively, at 6 months follow-up	No
Secondary	Emotions	Responses to the Positive and Negative Affective Scale (PANAS) compared to baseline	At baseline, at 3 days postoperatively, at 6 months follow-up	No
Secondary	Health-related Quality of life	Responses to the Short Form Health Survey (SF-36) compared to baseline	At baseline, at 6 months follow-up	No
Secondary	Self-esteem	Responses to the Rosenberg Self-esteem Scale (SES) compared to baseline	At baseline, at 6 months follow-up	No
Secondary	Qualitative dimension of pain	Responses to the McGill Pain Questionnaire - short form (SF-MPQ) compared to baseline	At baseline, following coldpressor test, at 3 days postoperatively, at 6 weeks follow-up, at 6 months follow-up	No
Secondary	Pain interference with daily life	Responses to the Brief Pain Inventory - short form (SF-BPI) compared to baseline	At baseline, at 6 weeks follow-up, at 6 months follow-up	No
Secondary	Course of pain	Course of pain is defined as 1.) constant pain with few fluctuations, 2.) constant pain with breakthrough pain, 3.) Breakthrough pain without pain in between, 4.) Breakthrough pain with pain in between.	At 6 weeks follow-up, at 6 months follow-up	No