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Dexmedetomidine for Prevention of Chronic Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03275207
Recruitment Status : Unknown
Verified December 2017 by Jian-jun Yang, Zhongda Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Jian-jun Yang, Zhongda Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Postoperative Pain Drug: saline Drug: dexmedetomidine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: paitents undergoing breast or thoracic surgery
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: control group
an equal volume of saline
 Drug: saline
an equal volume of saline
Experimental: dexmedetomidine
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
 Drug: dexmedetomidine
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative


Outcome Measures
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Primary Outcome Measures :
  1. the pain intensity measure [ Time Frame: 12 months ]
    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 :
  1. anxiety [ Time Frame: 12 months ]
    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)

  2. depression [ Time Frame: 12 months ]
    The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire

  3. sleep disturbance [ Time Frame: 12 months ]
    Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275207


Contacts
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Contact: Yang Jian-jun, PhD 13357739238 yjyangjj@126.com
Contact: Wang Xing-ming 18205185859 mingxingwang2011@163.com

Locations
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China, Jiangsu
Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Yang Jian-jun, PhD Zhongda Hospital
More Information
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Responsible Party: Jian-jun Yang, director, department of anesthesiology, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT03275207    
Other Study ID Numbers: 20170819
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian-jun Yang, Zhongda Hospital:
Chronic pain
CPSP
Dexmedetomidine
Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action