Dexamethasone Palmitate, Pain, Postoperative
Conditions
Brief summary
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.
Interventions
Patients 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.
DRUGDexamethasone
Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
Sponsors
Beijing Tiantan Hospital
Beijing Ditan Hospital
Beijing Electric Power Hospital
Beijing Sanbo Brain Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
1. Due to the visually distinct formulations-an opaque, white suspension (dexamethasone palmitate) versus a transparent solution (conventional dexamethasone)-blinding of the anaesthesiologists will not be feasible. 2. This unavoidable lack of blinding at the point of administration made it highly probable that the attending surgeons and the participants themselves could become aware of the treatment group assignment. 3. All postoperative follow-up evaluations will be conducted by outcome assessors who remain fully blinded to group allocation throughout the study. 4. The biostatistician will be blinded and will have no access to interim data until database lock.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years. 2. 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). 3. Capacity to comprehend the study procedures and assessment scales, and communicate effectively with research staff. 4）Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III. 5\) Willingness to participate voluntarily and provide written informed consent.
Exclusion criteria
1. Known hypersensitivity to dexamethasone or its excipients. 2. Systemic glucocorticoid therapy within 3 months prior to enrolment. 3. History of severe cardiovascular disease, hepatic or renal failure, or systemic rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus). 4. Coexisting chronic pain at enrolment. 5. Uncontrolled diabetes mellitus or active systemic infection. 6. Use of any systemic or topical analgesics within 48 hours prior to surgery. 7. Significant cognitive impairment or severe psychiatric disorder. 8. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of participants experiencing moderate to severe pain | 24 hours after surgery | The percentage of participants experiencing moderate to severe pain (Visual Analog Scale \[VAS\]\>30 mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total PCA attempts | Within the first 72 hours postoperatively | Participant' total PCA attempts patients' total PCA attempts patients' total PCA attempts |
| Cumulative opioid consumption | At 6, 24, 48, and 72 hours postoperatively | Cumulative opioid consumption, expressed as morphine milligram equivalents (MME) |
| The total consumption of supplemental oxycodone/paracetamol tablets | At 6, 24, 48, and 72 hours postoperatively | The total consumption of supplemental oxycodone/paracetamol tablets, expressed as the number of tablets |
| The proportion of participants experiencing moderate to severe pain | At 6, 24, 48, and 72 hours postoperatively | 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 to first patient-controlled analgesia (PCA) bolus request | Within the first 72 hours postoperatively | Time to first PCA bolus request |
| Participant satisfaction with pain management | At 6, 24, 48, and 72 hours postoperatively and at discharge | Using a 0-10 point numerical rating scale (NRS) (0 = very dissatisfied to 10 = most satisfied imaginable) |
| Incidences of postoperative nausea and vomiting (PONV) | At 6, 24, 48, and 72 hours after surgery | PONV is defined as any nausea, vomiting, retching, or combination thereof. Nausea refers to an unpleasant sensation associated with the urge to vomit; vomiting is defined as the forceful expulsion of gastric contents; and retching indicates an involuntary attempt to vomit without producing gastric contents. |
| Quality of recovery | At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery. | Quality of recovery will be measured using the 15-item quality of recovery scoring system \[QoR-15\] questionnaire. The total score ranges from 0 to 150, where higher scores indicate a better quality of recovery. |
| Length of hospital stay | From the date of hospital admission to the date of discharge, assessed throughout the hospitalization period (up to 1 month). | Length of hospital stay was defined as the number of days from the date of hospital admission to the date of discharge. |
| Pain intensity | upon arrival in the PACU after the patient becomes conscious (0 hour), and at 6, 24, 48, and 72 hours postoperatively, as well as at discharge, and at 1 month, 3 month, and 6 month follow up. | (0 = no pain, 100mm = worst imaginable pain) |
| Incidence of postoperative adverse events | Within six month after surgery | This outcome measure assesses the occurrence of specified safety events within six month after surgery. The number of participants experiencing any of the following confirmed events will be recorded and reported based on clinical examination, medical record review, and necessary laboratory tests: hypotension, hypertension, gastrointestinal ulcers, poor wound healing, surgical site infection, urinary retention, and hyperglycemia. Data will be aggregated and reported as event frequency and participant count. |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed