Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

Asklepieion Voulas General Hospital

Status and phase: Enrolling; Phase 2

Conditions: Total Hip Arthroplasty; Analgesia

Treatments: Drug: Levobupivacaine; Drug: Levobupivacaine plus nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06577155

10542/22-05-2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status according to American Society of Anesthesiologists (ASA) I-III
• Patients scheduled for total hip arthroplasty

Exclusion criteria

• BMI above 40
• Serious psychiatric, mental and cognitive disorders
• Contraindication for central and/or peripheral nervous blockade
• History of allergic or other adverse reactions on the agents used in the study
• Chronic opioid

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

E

Active Comparator group

Description:

Spinal levobupivacaine

Treatment:

Drug: Levobupivacaine

N

Active Comparator group

Description:

Spinal levobupivacaine plus nalbuphine

Treatment:

Drug: Levobupivacaine plus nalbuphine