E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postbariatric abdominoplasty |
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E.1.1.1 | Medical condition in easily understood language |
After gastric-bypass surgery, loss of weight may cause medical problems resolved by abdominoplasty. This involves large wounds and often postoperative pain which this trial aims to improve |
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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 |
To compare the preoperative analgesic effect of a preoperative quadratus lumborum block using 0.375% ropivacaine with that of placebo. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to observe patient satisfaction, and other practical aspects of the intervention in relation to the postoperative period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• American Society of Anesthesiologists Physical Classification Status (ASA) I-II
• Age 18 to 64
• Weight above or equal to 60 kg
• Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
• Patient is expected able to cooperate during the treatment and follow up. Signed informed consent obtained and documented according to ICH GCP, and national/local regulations. |
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E.4 | Principal exclusion criteria |
• a history of anaphylactic shock
• cardiovascular disease other than hypertension and/or hyperlipidemia
• known allergy to ropivacaine or morphine
• a history of chronic pain
• psychiatric comorbidity
• scheduled pain medication or neuroleptic drugs
• coagulation disorders or treatment with platelet inhibitors
• treatment with class III antiarrhytmics, sertindole, ziprasidone, amisulpride, citalopram, escitalopram, ceritinib, hydroxizine, fluvoxamine
• any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form). |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Postoperative opioid consumption, opioids other than intravenous morphine will be converted to equianalgesic doses of intravenous morphine according to standard tables |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• The average pain defined as numerical rating scale (NRS) area under curve (AUC) divided by the time spent at the postoperative ward.
• Time to first opioid dose
• Number of re-operations due to suspected bleeding
• Duration of surgery
• Total amount of local anesthetics
• Side effects and complications
• Patient satisfaction
• Time spent that the postoperative ward
• The effect of the QL block as evaluated in a linear mixed effects model where NRS equals opioid consumption plus QL block plus sex. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Respectively;
-Time of discharge from postoperative ward
-time of first opioid dose
-time of reoperation(s)
-in the postoperative ward
-in the postoperative ward
-upon discharge
-upon discharge from the postoperative ward
-at 24 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 | Yes |
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 | 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |