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Dexmedetomidine for Prevention of Chronic Postoperative Pain

a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03275207
Enrollment
120
Registered
2017-09-07
Start date
2018-01-01
Completion date
2018-10-01
Last updated
2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Postoperative Pain

Keywords

Chronic pain, CPSP, Dexmedetomidine, 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.

Interventions

DRUGsaline

an equal volume of saline

DRUGdexmedetomidine

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

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

paitents undergoing breast or thoracic surgery

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the pain intensity measure12 monthsSelf 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

MeasureTime frameDescription
anxiety12 monthsThe 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)
depression12 monthsThe depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire
sleep disturbance12 monthsSleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.

Countries

China

Contacts

Primary ContactYang Jian-jun, PhD
yjyangjj@126.com13357739238
Backup ContactWang Xing-ming
mingxingwang2011@163.com18205185859

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026