Efficacy of Intrathecal Morphine for Postoperative Analgesia with or without Suprainguinal Fascia Iliaca Block After Total Hip Arthroplasty: A Double-Blind Randomized Clinical Trial

Phase 1

Active, not recruiting

• Conditions: Total hip arthroplasty under spinal anesthesia; Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

• Registration Number: CTIS2024-511946-38-00
• Lead Sponsor: Centre hospitalier universitaire de Liege

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

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%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified