Back to resultsDexmedetomidine for Prevention of Chronic Postoperative Pain
Primary Purpose
Chronic Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
saline
dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Postoperative Pain focused on measuring Chronic pain, CPSP, Dexmedetomidine, Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongda Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
dexmedetomidine
Arm Description
an equal volume of saline
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
anxiety
The anxiety will be self reported by patents at day 1 before surgery, month 3, month 6, month 12 after surgery.The anxiety will be scored by a Visual Analogue Scale of anxiety (0=no anxiety, 10=worst possible anxiety)
depression
The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire
sleep disturbance
Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03275207
Brief Title
Dexmedetomidine for Prevention of Chronic Postoperative Pain
Official Title
a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after surgery. It is most common in patients who undergoing breast or thoracic surgery. Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after surgery. In our study, patients were randomly assigned to one of the two group to receive 0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Postoperative Pain
Keywords
Chronic pain, CPSP, Dexmedetomidine, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
paitents undergoing breast or thoracic surgery
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
an equal volume of saline
Arm Title
dexmedetomidine
Arm Type
Experimental
Arm Description
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
an equal volume of saline
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Primary Outcome Measure Information:
Title
the pain intensity measure
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
anxiety
Description
The anxiety will be self reported by patents at day 1 before surgery, month 3, month 6, month 12 after surgery.The anxiety will be scored by a Visual Analogue Scale of anxiety (0=no anxiety, 10=worst possible anxiety)
Time Frame
12 months
Title
depression
Description
The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire
Time Frame
12 months
Title
sleep disturbance
Description
Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Jian-jun, PhD
Phone
13357739238
Email
yjyangjj@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Xing-ming
Phone
18205185859
Email
mingxingwang2011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Jian-jun, PhD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexmedetomidine for Prevention of Chronic Postoperative Pain
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