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Dexmedetomidine for Prevention of Chronic Postoperative Pain

S

Southeast University

Status and phase

Unknown
Phase 4

Conditions

Chronic Postoperative Pain

Treatments

Drug: dexmedetomidine
Drug: saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03275207
20170819

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

control group
Placebo Comparator group
Description:
an equal volume of saline
Treatment:
Drug: saline
dexmedetomidine
Experimental group
Description:
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
Treatment:
Drug: dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Wang Xing-ming; Yang Jian-jun, PhD

Data sourced from clinicaltrials.gov

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