The Effect of Perioperative Dexamethasone Administration on Postoperative Pain in Patients Undergoing Periacetabular Osteotomy: A Randomised Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cumulated postoperative morphine consumption in milligrams after 48 hours.
研究概览
简要总结
This is an investigator-initiated, Danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (PAO). 90 adults undergoing PAO will be enrolled.
The primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours.
Key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: Perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing PAO due to symptomatic hip dysplasia (CE<25grader) or retroverted acetabulum (crossover and posterior wall sign)
- •≥ 18 years
- •Females if fertile: Verified negative human chorionic gonadotropin (HCG), usage of safe contraceptives or surgical sterilisation.
- •Patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions.
排除标准
- •Patients who cannot speak or understand Danish
- •Allergy or contraindications to trial medication
- •Spinal anaesthesia
- •Second intervention carried out simultaneously (e.g. femur osteotomy)
- •Patients with daily opioid consumption prior to surgery (tramadol and codeine accepted)
- •Drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively.
- •Mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants)
- •Diabetes diagnosed prior to inclusion
- •Immune suppression therapy (e.g. systemic glucocorticoids)
- •Kidney impairment (eGFR < 50ml/min) or liver disease (≥Child Pugh B)
研究组 & 干预措施
A; Dexamethasone twice
24mg intravenous Dexamethasone (Dexavital®, Vital Pharma) 4mg/ml just before the operation and repeated after 24 hours.
干预措施: Dexamethasone 24mg Solution for Injection (Drug)
B; Dexamethasone once
24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
干预措施: Dexamethasone 24mg Solution for Injection (Drug)
B; Dexamethasone once
24mg intravenous Dexamethasone just before the operation and placebo which is 6ml of isotonic sodium chloride (9mg/ml, 'normal' saline) after 24 hours
干预措施: Saline Solution for Injection (Drug)
C; Placebo twice
placebo intravenous just before the operation and repeated after 24 hours
干预措施: Saline Solution for Injection (Drug)
结局指标
主要结局
Cumulated postoperative morphine consumption in milligrams after 48 hours.
时间窗: 0-48 hours postoperatively
Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine and any other supplemental morphine administered postoperatively. Consumption in mg.
次要结局
- Cumulated postoperative morphine consumption from 48 hours until day 14 post operation(48 hours - day 14 postoperatively)
- Postoperative pain intensity after 48 hours.(24, 48 hours postoperatively)
- Postoperative nausea and vomiting(24 and 48 hours postoperatively)
- Antiemetic consumption(0-48 hours postoperatively)
- Sleep(0-7 days postoperatively)
- Timed up and go test(24, 48 hours postoperatively)
- Serious adverse events (SAE)(0-8 weeks after operation)
研究者
Viktoria Lindberg-Larsen
MD, PhD, principal investigator and sponsor
Odense University Hospital