2024-511946-38-00招募中4 期
Efficacy of Intrathecal Morphine for Postoperative Analgesia with or without Suprainguinal Fascia Iliaca Block After Total Hip Arthroplasty: A Double-Blind Randomized Clinical Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.
研究概览
简要总结
The primary objective is to demonstrate the usefulness of intrathecal administration of morphine (ITM) with or without ropivacaine in supra-inguinal fascia iliaca compartment block (SFIB) in total hip arthrpplasty (THA) to improve analgesia and reduce pain at mobilization (numeric rating scale, NRS 0 to 10) 8 hours after surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult man/women over 18 and less 85 years old
- •American Society of Anesthesiologists (ASA) Physical Status 1 or 2 or 3
- •Able to speak, read and understand French
- •Admitted for scheduled elective total hip replacement surgery with spinal anesthesia
排除标准
- •Pregnant women (or woman of childbearing potential who are breastfeeding or not taking an effective contraception, defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly, cfr. CTFG Guidelines “Recommendations related to contraception and pregnancy testing in clinical trials”)
- •Any patients where intrathecal morphine low dose (100 mcg) is contraindicated
- •Patients over 85 years old
- •Acute respiratory failure
- •Patients with acute abdominal syndrome, spasm of the sphincter of Oddi, bile duct contraction, pyloric spasm, intracranial hypertension, convulsive states, coma.
- •Patients with alcohol intoxication, barbiturate intoxication or acute porphyria.
- •Patients with peripheral neuropathy or other severe neurological pathology
- •Patients unable to give consent
- •Patients with chronic pain syndromes or chronic opioid addiction (more than 20 mg per day of equivalents oral morphine)
- •Chronic renal failure (glomerular filtration rate < 45 mL/min/1.73 m2)
- •Severe liver failure
- •Recent (<12 months) thrombo-embolic events
- •Suspected or confirmed allergy to local anesthetics or morphine
- •Allergy or hypersensitivity to the active ingredient or to any of the excipients of MORPHINE HCl STEROP, MINI-PLASCO NaCl BBRAUN 0,9% or Naropin 0.75%
结局指标
主要结局
The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.
The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.
次要结局
- Patient's pain related experience assessed by the International Pain Outcome (IPO) questionnaire at D2
- Quality-of-Recovery 15-items (QoR-15) score for assessment of functional recovery on D1, D2, day-7 (D7) and day-30 (D30)
- Total consumption of morphine equivalents during the first 48 hours post- operatively, through IV administration of morphine on a Patient Controlled Intravenous Analgesia (PCIA) device.
- NRS pain scores at rest and mobilization at fixed times: 8 hours after surgery, at 8:00 am, 1:00 pm and 6:00 pm on the first (D1) and second (D2) day after surgery (pain trajectory)
- Postoperative complications such as: orthostatic intolerance, falls and postoperative nausea and vomiting
- Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness
研究者
Michele Carella
Scientific
Centre hospitalier universitaire de Liege
研究点 (1)
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