Dexmedetomidine for Prevention of Chronic Postoperative Pain

Phase 4

• Conditions: Chronic Postoperative Pain
• Interventions: Drug: saline; Drug: dexmedetomidine

• Registration Number: NCT03275207
• Lead Sponsor: Zhongda Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-05
• Study Start: 2018-01-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	saline	an equal volume of saline
dexmedetomidine	dexmedetomidine	dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China