Dexmedetomidine for Prevention of Chronic Postoperative Pain

Chronic Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03275207
• Other study ID #: 20170819
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 23, 2017
• Last updated: December 3, 2017
• Start date: January 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: December 2017
• Source: Zhongda Hospital
• Contact: Yang Jian-jun, PhD
• Phone: 13357739238
• Email: yjyangjj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

Drug:
• saline
an equal volume of saline
• dexmedetomidine
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pain intensity measure	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)	12 months
Secondary	anxiety	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)	12 months
Secondary	depression	The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire	12 months
Secondary	sleep disturbance	Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.	12 months