Predictors of Postoperative Pain
2 other identifiers
interventional
60
1 country
2
Brief Summary
The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Jul 2012
Typical duration for not_applicable postoperative-pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 16, 2014
September 1, 2013
1.7 years
September 28, 2011
May 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain scores from IV insertion
15 minutes prior to induction
Secondary Outcomes (7)
Anxiety
24 to 48 hours before surgery
Pain from thermal stimuli
24 to 48 hours before surgery
Suprathreshold Thermal pain intensity
24 to 48 hours before surgery
suprathreshold thermal unpleasantness intensity
24 to 48 hours before surgery
Expectation about pain
24 to 48 hours before surgery
- +2 more secondary outcomes
Study Arms (1)
Patients undergoing hysterectomy
NO INTERVENTIONInterventions
Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site. To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C. To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C).
Eligibility Criteria
You may qualify if:
- Patients undergoing abdominal hysterectomy through a pfannenstiel incision
- American Society of Anesthesiologists (ASA)Class I-III
You may not qualify if:
- Patients with a history of psychiatric disease
- Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
- chronic opioid or nonsteroidal antiinflammatory drug use
- chronic pain conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
American Unversity of Beirut Medical Center
Beirut, Lebanon
AUBMC
Beirut, Lebanon
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie T Aouad, MD
American University of Beirut Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
October 10, 2011
Study Start
July 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 16, 2014
Record last verified: 2013-09