Prediction and Characterization of Acute and Chronic Postoperative Pain

NCT ID: NCT01308385

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-10-31

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 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.

Conditions

Pain; Pain, Postoperative; Funnel Chest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with pectus excavatum

Conditioned pain modulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lene Vase, Cand.psyc, PhD

Role: STUDY_CHAIR

University of Aarhus

Mogens Pfeiffer-Jensen, MD, PhD

Role: STUDY_CHAIR

Department of Rheumatology, Aarhus University Hospital

Hans K Pilegaard, MD

Role: STUDY_DIRECTOR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Asbjørn M Drewes, Prof., MD, PhD, DMsc

Role: STUDY_CHAIR

Mech-Sense, Department of Gastroenterology, Aarhus University Hospital, Aalborg Hospital,

Vibeke E Hjortdal, Prof., MD, PhD, DMSc

Role: STUDY_CHAIR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Kasper Grosen, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

Locations

Department of Cardiothoracic and Vascular Surgery

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

MIRPEX-2

Identifier Type: -

Identifier Source: org_study_id