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Efficacy of Intrathecal Morphine for Postoperative Analgesia with or without Suprainguinal Fascia Iliaca Block After Total Hip Arthroplasty: A Double-Blind Randomized Clinical Trial
EU CTIS ID: 2024-511946-38-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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%
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.