Dexmedetomidine for Prevention of Chronic Postoperative Pain

Sponsor

Zhongda Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03275207

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

13.4

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

paitents undergoing breast or thoracic surgerypaitents 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

Anticipated Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

the pain intensity measure [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.