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Dexmedetomidine for Prevention of Chronic Postoperative Pain

NCT ID: NCT03275207

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Chronic Postoperative Pain

Keywords

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Chronic pain CPSP Dexmedetomidine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

paitents undergoing breast or thoracic surgery
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control group

an equal volume of saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

an equal volume of saline

dexmedetomidine

dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative

Interventions

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saline

an equal volume of saline

Intervention Type DRUG

dexmedetomidine

dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian-jun Yang

director, department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Jian-jun, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Yang Jian-jun, PhD

Role: CONTACT

Phone: 13357739238

Email: [email protected]

Wang Xing-ming

Role: CONTACT

Phone: 18205185859

Email: [email protected]

Other Identifiers

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20170819

Identifier Type: -

Identifier Source: org_study_id