E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain following percutaneous nephrolithotomy. |
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E.1.1.1 | Medical condition in easily understood language |
Kidneystone removal by minimally invasive surgery. |
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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 | LLT |
E.1.2 | Classification code | 10059805 |
E.1.2 | Term | Nephrolithotomy |
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 |
We aim to optimize an opioid sparing regional anesthetic technique by optimizing the peripheral nerve blockade dosage, thus reducing both ORADEs as well as minimizing the amount of local anesthetic administered. The TQL block has been shown to exert a significant positive effect on postoperative pain management following PNL surgery administering 30 ml of ropivacaine 0.75% with a unilateral TQL block. We want to investigate whether it was possible to reduce the volume of local anesthetic administered to minimize the risk of local anesthetic systemic toxicity (LAST), and still have maximum beneficial clinical efficacy. Therefore, we wish to conduct a biased coin up-and-down sequential design to direct estimation of the minimum effective volume (MEV90) of ropivacaine 0.75% in 90% of patients undergoing unilateral PNL surgery. |
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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 |
Scheduled for elective PNL surgery in general anesthesia with propofol and remifentanil
Age > 18 years at the date of inclusion
Have received thorough information, oral and written, and signed the “informed consent” form on participation in the trail
ASA score 1-3
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E.4 | Principal exclusion criteria |
Inability to cooperate
Inability to speak and understand Danish
Allergy to local anesthetics or opioids
Daily intake of opioids (evaluated by the investigators)
Drug and/or substance abuse
Local infection at the site of injection or systemic infection
Difficulty visualization of muscular and fascial structures in ultrasound visualization necessary to the block administration
Substantial co-morbidity, ASA >3
Pregnant or breastfeeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain intensity (NRS 0-10/10) measured 30 minutes after arrival to the Post-Anesthesia Care Unit will be our primary and only effect parameter to evaluate whether the administered volume resulted in block success or failure. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes after arrival to the Post-Anesthesia Care Unit (PACU). |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Dose-finding study using the biased coin up-and-down sequential design |
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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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |