Effect of Intravenous Dexamethasone Palmitate on Postoperative Pain Prevention
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 446
- Locations
- 1
- Primary Endpoint
- The percentage of participants experiencing moderate to severe pain
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Willingness to participate voluntarily and provide written informed consent.
Exclusion Criteria
- •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.
- •Uncontrolled diabetes mellitus or active systemic infection.
- •Significant cognitive impairment or severe psychiatric disorder.
- •Pregnancy or lactation.
Arms & Interventions
Dexamethasone palmitate group
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.
Intervention: dexamethasone palmitate (Drug)
Dexamethasone group
Patients in the dexamethasone group will receive an intravenous injection of 8 mg dexamethasone after induction of anaesthesia but prior to surgical incision.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
The percentage of participants experiencing moderate to severe pain
Time Frame: 24 hours after surgery
The percentage of participants experiencing moderate to severe pain (Visual Analog Scale \[VAS\]\>30 mm)
Secondary Outcomes
- Cumulative opioid consumption(At 6, 24, 48, and 72 hours postoperatively)
- The total consumption of supplemental oxycodone/paracetamol tablets(At 6, 24, 48, and 72 hours postoperatively)
- The proportion of participants experiencing moderate to severe pain(At 6, 24, 48, and 72 hours postoperatively)
- Time to first patient-controlled analgesia (PCA) bolus request(Within the first 72 hours postoperatively)
- Participant satisfaction with pain management(At 6, 24, 48, and 72 hours postoperatively and at discharge)
- Incidences of postoperative nausea and vomiting (PONV)(At 6, 24, 48, and 72 hours after surgery)
- Quality of recovery(At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.)
- Length of hospital stay(From the date of hospital admission to the date of discharge, assessed throughout the hospitalization period (up to 1 month).)
- Incidence of postoperative adverse events(Within one month after surgery)
Investigators
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital