Dexamethasone Palmitate for Postoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital
About this trial
Postoperative pain remains highly prevalent and inadequately managed in a significant proportion of surgical patients, often leading to delayed recovery, increased opioid consumption, and potential progression to chronic pain. While perioperative systemic dexamethasone is used for its anti-inflammatory and opioid-sparing effects, its efficacy is inconsistent, and concerns regarding systemic side effects persist. Dexamethasone palmitate, a novel lipophilic prodrug formulated as nanoparticle emulsion, leverages the enhanced permeability and retention effect to target inflammatory sites selectively, potentially offering superior anti-inflammatory and analgesic efficacy with reduced systemic exposure. This trial aims to evaluate whether preoperative intravenous dexamethasone palmitate is more effective than conventional dexamethasone in preventing moderate-to-severe postoperative pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years.
Scheduled for a range of surgeries under general anesthesia, including both minimally invasive procedures (such as video-assisted thoracoscopic surgery and laparoscopy) and open surgeries (such as thoracotomy, laparotomy, spinal surgery, total joint replacement, and mastectomy).
Capacity to comprehend the study procedures and assessment scales, and communicate effectively with research staff.
Disqualifiers
Known hypersensitivity to dexamethasone or its excipients.
Systemic glucocorticoid therapy within 3 months prior to enrolment.
History of severe cardiovascular disease, hepatic or renal failure, or systemic rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus).
Coexisting chronic pain at enrolment.
Trial design
Design model
Parallel
Treatments tested in this trial
dexamethasone palmitate
DrugPatients assigned to the dexamethasone palmitate group will receive an intravenous injection of 8 mg dexamethasone palmitate after induction of anaesthesia but prior to surgical incision.
Dexamethasone
DrugPatients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
Treatment groups
446 Participants
are divided into 2 treatment groupsGroup A: Dexamethasone palmitate groupExperimental treatment 1 intervention
Group B: Dexamethasone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of participants experiencing moderate to severe pain
The percentage of participants experiencing moderate to severe pain (Visual Analog Scale \[VAS\]\>30 mm)
Time frame
24 hours after surgerySecondary outcomes
1
Cumulative opioid consumption
Cumulative opioid consumption, expressed as morphine milligram equivalents (MME)
Time frame
At 6, 24, 48, and 72 hours postoperatively2
The total consumption of supplemental oxycodone/paracetamol tablets
The total consumption of supplemental oxycodone/paracetamol tablets, expressed as the number of tablets
Time frame
At 6, 24, 48, and 72 hours postoperatively3
The proportion of participants experiencing moderate to severe pain
The proportion of participants experiencing moderate to severe pain at rest and during passive movement (e.g., coughing, deep breathing, or following a 5 m walk test)
Time frame
At 6, 24, 48, and 72 hours postoperatively4
Time to first patient-controlled analgesia (PCA) bolus request
Time to first PCA bolus request
Time frame
Within the first 72 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Beijing Ditan Hospital
Collaborator
Beijing Electric Power Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Source ClinicalTrials.gov