Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01308385
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2011-03-03
Brief Title:
Prediction and Characterization of Acute and Chronic Postoperative Pain
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 individuals ability to modulate pain and consequently the individuals 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- andor 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
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 individuals ability to modulate pain and consequently the individuals 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- andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None