A Phase 2 interventional study of Levobupivacaine and Levobupivacaine plus nalbuphine in Total Hip Arthroplasty and Analgesia, sponsored by Asklepieion Voulas General Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment
60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.
Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Spinal levobupivacaine
Drug: Levobupivacaine
Spinal levobupivacaine plus nalbuphine
Drug: Levobupivacaine plus nalbuphine
Regional anesthesia / analgesia
Drug pages: Levobupivacaine · Nalbuphine
Regional anesthesia / analgesia
Morphine consumption
Time frame: 24 hours
NRS scores
Time frame: 48 hours
sensory block level
Time frame: 1 hour
motor block level
Time frame: 1 hour
sensory block onset
Time frame: 1 hour
motor block onset
Time frame: 1 hour
sensory block duration
Time frame: 4 hours
motor block duration
Time frame: 4 hours
Complications
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Jan 2025, 4 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levobupivacaine · Nalbuphine
Agnosia
Asklepieion Voulas General Hospital