E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Total hip arthroplasty by postero-lateral approach |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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 |
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E.5.2 | 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. |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
The originality of our study is that it is the first randomized non-inferiority trial between PENG block and SFICB in THA by posterolateral approach.
Finally, if the PENG block will provide a non-inferiority opioid-sparing as SFICB as we hypothesized, the interest of the PENG will be the motor sparing for an enhanced recovery after surgery in first 24 hours. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Randomized non-inferiority clinical trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is reached at the last visit of the last subject at the end of hospitalization and/or day 7 after surgery |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |