PANDORA: Paravertebral AdjuNctive DexamethasOne Palmitate Reducing Chronic Pain After Caridiac Surgery

NCT05920967 | Active Not Recruiting DMC

• 1 other identifier: KY20232194-C-1
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The incidence of chronic postoperative pain

  Pain status score on the Brief Pain Inventory（BPI-NRS score range, 0-10; ≥1 indicates it happens）

  3 months after surgery

Secondary Outcomes (12)

• Morphine consumption

  24, 48, 72 hours after surgery

• The incidence of acute pain at resting and activity

  24, 48, 72 hours after surgery

• The incidence of chronic postoperative pain

  6 and 12 months after surgery

• Pain severity in the past 7 days

  3, 6, 12 months after surgery

• Pain severity in the past 24 hours

  3, 6, 12 months after surgery

Study Arms (2)

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.

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.

Drug: Dexamethasone Sodium Phosphate

Interventions

Dexamethasone Palmitate DRUG

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.

DXP group

Dexamethasone Sodium Phosphate DRUG

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.

DXM group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA class I-III
• years to 65 years
• Undergoing intercostal incision cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 39819928 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-palmitate; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chong Lei, MD&phD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• Taoyuan Zhang, M.D.

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 27, 2023
• Study Start: July 11, 2023
• Primary Completion: September 18, 2024
• Study Completion: December 30, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

CN (1)