Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine for Prevention of Chronic Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 23, 2017
First Posted Date  ICMJE September 7, 2017
Last Update Posted Date December 5, 2017
Estimated Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
  • 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)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • anxiety [ Time Frame: 12 months ]
    The anxiety will be self reported by paitents at day 1 before sugery, 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 [ Time Frame: 12 months ]
    The depression will be evaluated at day 1 before sugery, month 3, month 6, month 12 after sugery by a questionnaire
  • sleep disturbance [ Time Frame: 12 months ]
    Sleep disturbance will be evaluated at day 1 before sugery, month 3, month 6, month 12 after sugery by questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine for Prevention of Chronic Postoperative Pain
Official Title  ICMJE a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
paitents undergoing breast or thoracic surgery
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Chronic Postoperative Pain
Intervention  ICMJE
  • Drug: saline
    an equal volume of saline
  • Drug: dexmedetomidine
    dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Study Arms  ICMJE
  • Placebo Comparator: control group
    an equal volume of saline
    Intervention: Drug: saline
  • Experimental: dexmedetomidine
    dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
    Intervention: Drug: dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2018
Estimated Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03275207
Other Study ID Numbers  ICMJE 20170819
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian-jun Yang, Zhongda Hospital
Study Sponsor  ICMJE Zhongda Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yang Jian-jun, PhD Zhongda Hospital
PRS Account Zhongda Hospital
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP