Dexmedetomidine for Prevention of Chronic Postoperative Pain
a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
1 other identifier
interventional
120
1 country
1
Brief Summary
Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2018
Shorter than P25 for phase_4
1 active site
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
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedDecember 5, 2017
December 1, 2017
9 months
August 23, 2017
December 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the pain intensity measure
Self reported pain intensity in rest and activity will be recorded at day 1 before sugery, month 3, month 6, month 12 after sugery. The intensity of pain was measured by numeric rating scale (0=no pain, 10=worst possible pain)
12 months
Secondary Outcomes (3)
anxiety
12 months
depression
12 months
sleep disturbance
12 months
Study Arms (2)
control group
PLACEBO COMPARATORan equal volume of saline
dexmedetomidine
EXPERIMENTALdexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Interventions
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Eligibility Criteria
You may qualify if:
- Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
You may not qualify if:
- Patients with limitations of self-expression or visual dysfunction or having emergency surgery, a severe psychiatric illness, or chronic pain problems in the chest area for longer than 2 months before the surgery,or patients who could not provide informed consent were excluded.
- Pregnant women and prisoners were also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Zhongda Hospital
Nanjing, Jiangsu, 210009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang Jian-jun, PhD
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director, department of anesthesiology
Study Record Dates
First Submitted
August 23, 2017
First Posted
September 7, 2017
Study Start
January 1, 2018
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
December 5, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share