Total hip arthroplasty by postero-lateral approach
Conditions
Interventions
Trade Name: Naropin
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Ropivacaine hydrochloride
Other descriptive name: ROPIVACAINE HYDROCHLORIDE
Concentration
Sponsors
CHU de Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients >18 years old Classified as ASA 1-2-3 Admitted for elective total hip arthroplasty surgery by poster-lateral approach under spinal anesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusion criteria included refusal of the patient and contraindications to the performance of SFICB or PENG block such as known allergy to used medications or local infection. Other exclusion criteria included pregnancy, obesity with body mass index > 35, emergency hip arthroplasty or previous surgery on the same joint, history of drug addiction, treatment with corticosteroids for more than 6 months, uncontrolled systemic arterial hypertension, severe kidney or liver diseases, and mental disorders or serious neurological diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study we primarily aimed at evaluating the influence of ropivacaine SFICB or PENG block on postoperative pain at rest and at mobilization in patients receiving spinal anesthesia for THAPL and the non-inferiority of PENG block on postoperative pain, opioid-sparing and global functional outcomes.;Secondary Objective: Secondary end points were the evaluation of contribution of SFICB and PENG block on pain perception, recovery satisfaction, incidence of side effects related to opioids, orthostatic intolerance and contribution of the SFICB on functional walking performance in first 48 hours after surgery, QOR-15 score.;Primary end point(s): The primary endpoint of the study will be the between-group comparisons in postoperative NRS pain scores (rest and dynamic) and related opioid consumption.;Timepoint(s) of evaluation of this end point: - 1 hour and 6 hours after surgery - At 8 am, 1 pm and 6 pm on first and second day after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints were the evaluation of distance traveled at 2-minute walk test at day-1 after surgery, as well as the distance traveled at 6-minute walk test at day-2 after surgery, the between-group comparisons in postoperative complications such as orthostatic intolerance, incidence of side effects related to morphine consumption at day-1 and day-2 after surgery, such as postoperative nausea and vomiting, bladder globe, delayed resumption of intestinal transit or constipation, dizziness and discomfort, total length of stay and days of hospitalization and pain management satisfaction score by revised American Pain Society Patient Outcomes Questionnaire (APS-POQ-R) and QoR-15 score.;Timepoint(s) of evaluation of this end point: - 1 hour and 6 hours after surgery - At 8 am, 1 pm and 6 pm on first and second day after surgery - 1st day for 2-minute walk test - 2nd day after surgery for 6-minute walk test - At the end of hospitalisation | — |
Countries
Belgium
Contacts
Public ContactMichele Carella
CHU de Liège
Outcome results
None listed