Chronic Postoperative PainPhase 4NCT03275207
Dexmedetomidine for Prevention of Chronic Postoperative Pain
A Phase 4 study testing saline and dexmedetomidine in people with Chronic Postoperative Pain, run by Zhongda Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- saline and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
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.
Read the 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.
- Conditions
- Chronic Postoperative Pain
- Being tested
- saline, dexmedetomidine
- Keywords
- Chronic pain, CPSP, Dexmedetomidine, Surgery
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
an equal volume of saline
dexmedetomidineDrug
dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | an equal volume of saline Receives: Drug: saline |
| dexmedetomidine | Experimental | dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 12 months
depression
The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire
Measured: 12 months
sleep disturbance
Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- paitents undergoing breast or thoracic surgery
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Yang, Zhongda Hospital
- Investigators
- Yang Jian-jun, PhD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275207
- Sponsor's protocol ID
- 20170819
- Status last verified
- Dec 2017
- First submitted
- 23 Aug 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03275207
- Acronym / sponsor ID
- 20170819
- Conditions
- Chronic Postoperative Pain
- Keywords
- Chronic pain, CPSP, Dexmedetomidine, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- paitents undergoing breast or thoracic surgery
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: salinean equal volume of saline |
| dexmedetomidine | Experimental | Drug: dexmedetomidinedexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic surgery.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salinean equal volume of saline | Drug | control group |
| dexmedetomidinedexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative | Drug | dexmedetomidine |
Primary outcome
the pain intensity measure
Time frame: 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)
3 secondary outcomes
anxiety
Time frame: 12 months
depression
Time frame: 12 months
sleep disturbance
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Jian-jun, PhD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing saline and dexmedetomidine in people with Chronic Postoperative Pain, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Jian-jun, PhD (13357739238, yjyangjj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pain intensity measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.