E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary total knee arthroplasty |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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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 |
The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypoth-esis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard cath-eter. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age > 18 years old • Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia • Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions • ASA 1-3 • Ability to perform a TUG test preoperatively
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E.4 | Principal exclusion criteria |
• Patients who cannot cooperate • Patients who cannot understand or speak Danish. • Patients with allergy to the medicines used in the study • Patients with a daily intake of strong opioids (morphine, oxycodone, ketobe-midone, methadone, fentanyl) during the last 4 weeks • Patients suffering from alcohol and/or drug abuse – based on the investiga-tor's assessment • Rheumatoid arthritis • BMI > 40 • Neuromuscular pathology in the lower limbs • Pregnancy Pregnancy testing will be performed prior to inclusion in women of child bearing potential
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E.5 End points |
E.5.1 | Primary end point(s) |
• Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC), from end of surgery until 12 PM on POD 2. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From end of surgery until 12 PM on post-operative day 2 |
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E.5.2 | Secondary end point(s) |
• VAS pain scores (0–100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points. • VAS pain scores (0–100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points. • Worst pain (VAS, 0–100 mm) during the TUG test on POD 1 and 2. • Quadriceps strength assessed as MVIC in percentage of preoperative baseline values on POD 1 and 2. • Time (seconds) to perform the TUG test on POD 1 and 2. • Number of patients able to perform the TUG test, using a high 4-wheel walker, on POD 1 and 2. • 6 min walk test performed on POD 1 and 2, using a high 4-wheel walker.
As for the primary outcome, the secondary outcomes are also comparisons between the three groups: SB vs CC, SB vs SC and CC vs SC.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain will be assessed at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 Pm and 8 AM on POD 1 and finally at 8 AM and 12 PM on POD 2. Ambulation and muscle strength will be assessed at 12PM on POD 1 and POD 2 |
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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 | 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 | 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 | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
single bolus versus repeated intermittent boluses |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |