Dexamethasone Palmitate for Postoperative Pain

Beijing Tiantan Hospital446 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

446

Conditions

Pain, Postoperative Dexamethasone Palmitate

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 surgery

Secondary Outcomes

Cumulative opioid consumption

Cumulative opioid consumption, expressed as morphine milligram equivalents (MME)

Time frame: At 6, 24, 48, and 72 hours postoperatively

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 postoperatively

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 postoperatively

Time to first patient-controlled analgesia (PCA) bolus request

Time to first PCA bolus request

Time frame: Within the first 72 hours postoperatively

Participant satisfaction with pain management

Using a 0-10 point numerical rating scale (NRS) (0 = very dissatisfied to 10 = most satisfied imaginable)

Time frame: At 6, 24, 48, and 72 hours postoperatively and at discharge

Incidences of postoperative nausea and vomiting (PONV)

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.

Time frame: At 6, 24, 48, and 72 hours after surgery

Quality of recovery

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.

Time frame: At 24, 48, and 72 hours postoperatively, as well as at 1 month after surgery.

Length of hospital stay

Length of hospital stay was defined as the number of days from the date of hospital admission to the date of discharge.

Time frame: 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

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.

Time frame: Within six month after surgery

Pain intensity

(0 = no pain, 100mm = worst imaginable pain)

Time frame: 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.

total PCA attempts

Participant' total PCA attempts patients' total PCA attempts patients' total PCA attempts

Time frame: Within the first 72 hours postoperatively

Dexamethasone Palmitate for Postoperative Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts