Chronic Postoperative PainNCT05920967
PANDORA: Paravertebral AdjuNctive DexamethasOne Palmitate Reducing Chronic Pain After Caridiac Surgery
A study testing Dexamethasone Palmitate and Dexamethasone Sodium Phosphate in people with Chronic Postoperative Pain, run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this single-center, prospective, double-blind randomized controlled clinical trial is to explore preventive interventions for chronic postoperative pain (CPSP) in patients undergoing minimally invasive cardiac surgery. 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?
- Dexamethasone Palmitate and Dexamethasone Sodium Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 30 Oct 2025
- Phase
- Interventional
- 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
- NYHA class I-III
- 18 years to 65 years
- Undergoing intercostal incision cardiac surgery
Who cannot join
- Urgent surgery
- BMI≧35kg/m^2
- Non-first cardiac surgery
- Local anesthetic allergy
- Skin damage or infection at the puncture site
- Dysfunction of liver, kidney and blood coagulation
- Previously had chronic pains
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Paravertebral Nerve Block Combined With Dexamethasone Palmitate vs Combined With Dexamethasone Sodium Phosphate on Chronic Postoperative Pain in Patients Undergoing Minimally Invasive Cardiac Surgery
The goal of this single-center, prospective, double-blind randomized controlled clinical trial is to explore preventive interventions for chronic postoperative pain (CPSP) in patients undergoing minimally invasive cardiac surgery. The main questions it aims to answer is: the incidence of CPSP is high and severe, and there is no safe and effective method for prevention and treatment. The participants in the dexamethasone palmitate (DXP) group will receive a single paravertebral space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. The participants in dexamethasone sodium phosphate (DXM) group will receive a single infusion of a paravertebral space first dose of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Then both groups use a continuous paravertebral nerve block pump for postoperative analgesia. The liquid of the pump is 250 ml 0.2 percentage ropivacaine. The background of the pump is set to 5 ml/h and PCA is set to 5 ml at an interval of 30 min.
Read the detailed description
Minimally invasive cardiac surgery has the advantages of small injury, rapid recovery and international leadership. But the incidence of chronic pain after operation is high, which is reported to be as high as 70 percentage in thoracic intercostal surgery, seriously affecting the quality of life of patients after surgery. Uncontrolled acute pain after surgery poses the greatest risk factor for CPSP. Procedure-specific postoperative pain management (PROSPECT) guidelines recommend that the use of paravertebral nerve block as the first choice for multimodal analgesia in intercostal surgery can significantly reduce the incidence of postoperative acute pain. But there is not enough evidence to prove that it can reduce the incidence of CPSP. Choosing a reasonable combination of analgesics in nerve block to inhibit the production and transmission of multi-source nociceptive signals caused by intercostal nerve injury and inflammatory stimulation is one of the research hotspots to prevent the transformation from acute pain to chronic pain.
Dexamethasone can play an anti-inflammatory effect by reducing the sensitivity caused by neuroinflammation, which has also been confirmed by small sample studies. But a large number of literatures point out that a single use of dexamethasone cannot significantly reduce the incidence of CPSP. This may be due to the fact that the half-life of dexamethasone is only 48 hours, and single use is not enough to exert anti-inflammatory effects; long-term large-scale use can increase blood sugar concentration, leading to complications such as poor wound healing. From this, the investigators infer that finding a means or preparation to prolong the action time and efficacy of dexamethasone while reducing side effects may become an important means of preventing CPSP.
Dexamethasone palmitate is a kind of dexamethasone nanoparticles with long curative effect, good effect and few side effects. It plays a very significant therapeutic role in the late stage of inflammation and has been proved to prevent the progression of inflammation. And there have been studies on the injection of dexamethasone palmitate in epidural or perineural space, but the safety and efficacy of dexamethasone palmitate in paravertebral space need to be further studied.
The primary aim of this study is to compare whether single injection of dexamethasone palmitate and dexamethasone sodium phosphate around the paravertebral nerve combined with continuous paravertebral nerve block for postoperative analgesia can reduce the incidence of chronic pain 3 months after operation.
- Conditions
- Chronic Postoperative Pain
- Being tested
- Dexamethasone Palmitate, Dexamethasone Sodium Phosphate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone PalmitateDrug
a single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min.
Dexamethasone Sodium PhosphateDrug
a single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min.
| Study group | Role | What they receive |
|---|---|---|
| DXP group | Experimental | The participants in DXP group will receive a first dose of a single paravertebral space infusion of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. Receives: Drug: Dexamethasone Palmitate |
| DXM group | Active comparator | The participants in DXM group will receive a single infusion of a paravertebral space first dose of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Receives: Drug: Dexamethasone Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chronic postoperative pain
Pain status score on the Brief Pain Inventory（BPI-NRS score range, 0-10; ≥1 indicates it happens）
Measured: 3 months after surgery
Secondary outcomes (12)
Morphine consumption
Total consumption of rescue analgesia by oral morphine equivalent (mcg/kg)
Measured: 24, 48, 72 hours after surgery
The incidence of acute pain at resting and activity
Numerical Rating Scale to evaluate the incidence of pain (NRS score range, 0-10; ≥1 indicates it happens once)
Measured: 24, 48, 72 hours after surgery
The incidence of chronic postoperative pain
Pain status score on the Brief Pain Inventory（BPI-NRS score range, 0-10; ≥1 indicates it happens）
Measured: 6 and 12 months after surgery
Pain severity in the past 7 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v2.0 - Pain Intensity 3a (T-score range, 36.3-81.8; 81.8 indicates worst pain intensity)
Measured: 3, 6, 12 months after surgery
Pain severity in the past 24 hours
Brief Pain Inventory (BPI pain intensity score rang, 0-40; 40 indicates worst pain intensity)
Measured: 3, 6, 12 months after surgery
The interference of chronic postoperative pain on activities of daily living in the past 7 days
PROMIS Short Form v1.1 - Pain Interference 8a (PROMIS-PI-SF-8A; T-score range, 40.7-77; 77 indicates worst pain interference)
Measured: 3, 6, 12 months after surgery
The interference of chronic postoperative pain on activities of daily living in the past 24 hours
Brief Pain Inventory (BPI pain interference score rang 0-70; 70 indicates worst pain interference)
Measured: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on neuropathic pain
PROMIS Scale v2.0 - Neuropathic Pain Quality 5a (T-score range, 37.0-74.1; 74.1 indicates highly neuropathic pain)
Measured: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on health related quality of life
12-item Short-Form Health Survey v2 (SF-12 v2.0 scores range, 0-100, 100 indicates best functioning)
Measured: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on sleep quality
Pittsburgh Sleep Quality Index (PSQI score range, 0-21, 21 indicates worst sleep quality)
Measured: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on emotional wellbeing
Hospital Anxiety and Depression Scale (HADS score range, 0-21, 21 indicates worst anxiety or depression)
Measured: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on self-efficacy
Pain Self Efficacy Questionnaire (PSEQ score range, 0-60, 60 indicates strongest self-belief)
Measured: 3, 6, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start11 Jul 2023
- Primary completion18 Sep 2024
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Chong Lei, MD&phD, Principal investigator, Xijing HospitalTaoyuan Zhang, M.D., Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920967
- Sponsor's protocol ID
- KY20232194-C-1
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang H, Zhang T, Zheng Z, Gao J, Gao B, Hou L, Zhao J, Wang L, Dong H, Lei C. Rationale and design for the thoracic Paravertebral Adjunctive Dexamethasone Palmitate Reducing chronic pain After cardiac surgery (PANDORA) trial: a parallel-group, double-blinded, randomised controlled, single-centre study. BMJ Open. 2025 Jan 15;15(1):e086392. doi: 10.1136/bmjopen-2024-086392.
PubMed 39819928
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Paravertebral Nerve Block Combined With Dexamethasone Palmitate vs Combined With Dexamethasone Sodium Phosphate on Chronic Postoperative Pain in Patients Undergoing Minimally Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05920967
- Acronym / sponsor ID
- KY20232194-C-1
- Conditions
- Chronic Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 27 Jun 2023 (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.
The goal of this single-center, prospective, double-blind randomized controlled clinical trial is to explore preventive interventions for chronic postoperative pain (CPSP) in patients undergoing minimally invasive cardiac surgery. The main questions it aims to answer is: the incidence of CPSP is high and severe, and there is no safe and effective method for prevention and treatment. The participants in the dexamethasone palmitate (DXP) group will receive a single paravertebral space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. The participants in dexamethasone sodium phosphate (DXM) group will receive a single infusion of a paravertebral space first dose of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Then both groups use a continuous paravertebral nerve block pump for postoperative analgesia. The liquid of the pump is 250 ml 0.2 percentage ropivacaine. The background of the pump is set to 5 ml/h and PCA is set to 5 ml at an interval of 30 min.
Detailed description
Minimally invasive cardiac surgery has the advantages of small injury, rapid recovery and international leadership. But the incidence of chronic pain after operation is high, which is reported to be as high as 70 percentage in thoracic intercostal surgery, seriously affecting the quality of life of patients after surgery. Uncontrolled acute pain after surgery poses the greatest risk factor for CPSP. Procedure-specific postoperative pain management (PROSPECT) guidelines recommend that the use of paravertebral nerve block as the first choice for multimodal analgesia in intercostal surgery can significantly reduce the incidence of postoperative acute pain. But there is not enough evidence to prove that it can reduce the incidence of CPSP. Choosing a reasonable combination of analgesics in nerve block to inhibit the production and transmission of multi-source nociceptive signals caused by intercostal nerve injury and inflammatory stimulation is one of the research hotspots to prevent the transformation from acute pain to chronic pain.
Dexamethasone can play an anti-inflammatory effect by reducing the sensitivity caused by neuroinflammation, which has also been confirmed by small sample studies. But a large number of literatures point out that a single use of dexamethasone cannot significantly reduce the incidence of CPSP. This may be due to the fact that the half-life of dexamethasone is only 48 hours, and single use is not enough to exert anti-inflammatory effects; long-term large-scale use can increase blood sugar concentration, leading to complications such as poor wound healing. From this, the investigators infer that finding a means or preparation to prolong the action time and efficacy of dexamethasone while reducing side effects may become an important means of preventing CPSP.
Dexamethasone palmitate is a kind of dexamethasone nanoparticles with long curative effect, good effect and few side effects. It plays a very significant therapeutic role in the late stage of inflammation and has been proved to prevent the progression of inflammation. And there have been studies on the injection of dexamethasone palmitate in epidural or perineural space, but the safety and efficacy of dexamethasone palmitate in paravertebral space need to be further studied.
The primary aim of this study is to compare whether single injection of dexamethasone palmitate and dexamethasone sodium phosphate around the paravertebral nerve combined with continuous paravertebral nerve block for postoperative analgesia can reduce the incidence of chronic pain 3 months after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DXP group | Experimental | Drug: Dexamethasone PalmitateThe participants in DXP group will receive a first dose of a single paravertebral space infusion of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. |
| DXM group | Active comparator | Drug: Dexamethasone Sodium PhosphateThe participants in DXM group will receive a single infusion of a paravertebral space first dose of 21 ml of analgesic containing 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA class I-III
- 18 years to 65 years
- Undergoing intercostal incision cardiac surgery
Key exclusion criteria (7 listed)
- Urgent surgery
- BMI≧35kg/m^2
- Non-first cardiac surgery
- Local anesthetic allergy
- Skin damage or infection at the puncture site
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 |
|---|---|---|
| Dexamethasone Palmitatea single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone palmitate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min. | Drug | DXP group |
| Dexamethasone Sodium Phosphatea single paraverteal space infusion of 21 ml of the first dose of analgesia, consisting of 0.5 percentage ropivacaine 20 ml and dexamethasone sodium phosphate 1ml. Then, a continuous paraverteal nerve block pump was connected for postoperative analgesia. The liquid of the pump was 250 ml 0.2 percentage ropivacaine. The background of the pump was set to 5 ml/h and PCA was set to 5 ml at an interval of 30 min. | Drug | DXM group |
Primary outcome
The incidence of chronic postoperative pain
Time frame: 3 months after surgery
Pain status score on the Brief Pain Inventory（BPI-NRS score range, 0-10; ≥1 indicates it happens）
12 secondary outcomes
Morphine consumption
Time frame: 24, 48, 72 hours after surgery
The incidence of acute pain at resting and activity
Time frame: 24, 48, 72 hours after surgery
The incidence of chronic postoperative pain
Time frame: 6 and 12 months after surgery
Pain severity in the past 7 days
Time frame: 3, 6, 12 months after surgery
Pain severity in the past 24 hours
Time frame: 3, 6, 12 months after surgery
The interference of chronic postoperative pain on activities of daily living in the past 7 days
Time frame: 3, 6, 12 months after surgery
The interference of chronic postoperative pain on activities of daily living in the past 24 hours
Time frame: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on neuropathic pain
Time frame: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on health related quality of life
Time frame: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on sleep quality
Time frame: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on emotional wellbeing
Time frame: 3, 6, 12 months after surgery
The impact of chronic postoperative pain on self-efficacy
Time frame: 3, 6, 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Results publication: PubMed 39819928Zhang H, Zhang T, Zheng Z, Gao J, Gao B, Hou L, Zhao J, Wang L, Dong H, Lei C. Rationale and design for the thoracic Paravertebral Adjunctive Dexamethasone Palmitate Reducing chronic pain After cardiac surgery (PANDORA) trial: a parallel-group, double-blinded, randomised controlled, single-centre study. BMJ Open. 2025 Jan 15;15(1):e086392. doi: 10.1136/bmjopen-2024-086392.
- The published protocolLink provided by the sponsor.
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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.
Chong Lei, MD&phD principal investigator
Xijing Hospital
Taoyuan Zhang, M.D. principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Palmitate and Dexamethasone Sodium Phosphate in people with Chronic Postoperative Pain, run by Xijing 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 14 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chronic postoperative pain (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920967, which also lists 1 linked publication.
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 14 Oct 2026.