E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Total hip arthroplasty through minimal invasive muscle sparing surgery technique |
Totale heupprothesen met een minimaal invasieve spiersparende techniek |
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E.1.1.1 | Medical condition in easily understood language |
Total hip arthroplasty through a surgical technique in which muscles are spared as much as possible |
Plaatsing van totale heupprothesen door een minimaal invasieve techniek waarbij spieren zoveel mogelijk gespaard worden |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020096 |
E.1.2 | Term | Hip arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
To determine analgesia efficacy through the first postoperative week and at the 29-day follow up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty. |
Efficiëntie van pijnbestrijding nagaan na het toedienen van bupivacaine 0.25% of NaCl bij patiënten met een unilaterale heupprothese via de direct anterieure benadering gedurende de eerste week postoperatief en bij het opvolggesprek op dag 29. |
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E.2.2 | Secondary objectives of the trial |
To compare total opioid consumption through the first postoperative week and the 29-day follow-up call of patients given bupivacaine 0.25% or normal saline prior to unilateral direct anterior approach total hip arthroplasty.
To assess the onset and duration of sensory and motor blockade after fascia iliaca block for unilateral direct anterior approach total hip arthroplasty. |
Het totaal gebruik van opioïden gedurende de eerste week postoperatief en bij het opvolggesprek op dag 29, alsook de mate en de duur van sensorische en motorische uitval. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
● Male or female, at least 18 years of age at screening. ● Scheduled to undergo unilateral DAA THA ● American Society of Anesthesiologists (ASA) physical status 1, 2 or 3 ● Able to demonstrate sensory function by exhibiting sensitivity to light touch ● Able to ambulate ● Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
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E.4 | Principal exclusion criteria |
● Previous open hip surgery ● History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics Contraindication to bupivacaine or morphine |
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E.5 End points |
E.5.1 | Primary end point(s) |
NRS pain intensity scores reported through the first postoperative week and at the 29-day call |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- NRS at baseline (on Day 0 prior to the nerve block and prior to any premedication); upon arrival to and discharge from the PACU; at 6, 12, 24, 48, 72 h (inpatient), at Days 4, 5, 6 and 7 (outpatient, by phone), and at the 29-day follow-up call.
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E.5.2 | Secondary end point(s) |
Total postsurgical opioid consumption through the first postoperative week and at the 29-day call
Extent and duration of sensory and motor block through the 3-day inpatient stay
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Amount of opioid medication taken (IVPCA or oral) through the first 24 h, to the 48 and 72 h timepoints inclusive, at Days 4, 5, 6 and 7 (inclusive) and at the 29-day follow-up call.
● ● Sensory assessment (as measured by light touch testing) and degree of femoral nerve motor block (strength and angle of knee extension), degree of the obturator nerve block (adduction of the thigh) at baseline (on Day 0 prior to the nerve block); at approximately 15 and 30 minutes after the FIB; upon arrival at the PACU and at 12, 24 and 72 hours.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | 3 |
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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Patients can be included within one year from the start of the study. Evaluation will take longer until one month after the last patient is included. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |