The Effect of Nalbuphine as an Adjuvant to Levobupivacaine in Subarachnoid Anesthesia in Total Hip Arthroplasty. A Double-blind, Randomized, Controlled Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Physical status according to American Society of Anesthesiologists (ASA) I-III

• Patients scheduled for total hip arthroplasty

Locations
Other Locations
Greece
Asklepieion Hospital of Voula
RECRUITING
Athens
Contact Information
Primary
Anastasios Mpontozis
mpontozis405@gmail.com
+306938709796
Backup
Alexandros Makris
makrisalexandros@hotmail.com
+306947076446
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 60
Treatments
Active_comparator: E
Spinal levobupivacaine
Active_comparator: N
Spinal levobupivacaine plus nalbuphine
Related Therapeutic Areas
Sponsors
Collaborators: Anastasios Mpontozis
Leads: Asklepieion Voulas General Hospital

This content was sourced from clinicaltrials.gov