E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostatectomy Hysterectomy |
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E.1.1.1 | Medical condition in easily understood language |
Removal of the prostate or removal of the uterus |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
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 | 10061916 |
E.1.2 | Term | Prostatectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 | 10021151 |
E.1.2 | Term | Hysterectomy |
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 |
The aim of the present study is to assess if 10 mg intraoperative ketorolac is non-inferior to the standard 30 mg dose for the duration of efficacy in the treatment of acute postoperative pain . Therefore, a monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate ketorolac 10 mg is as effective for pain relief as the standard dose of 30 mg in patients undergoing robot assisted radical prostatectomy (RARP) or hysterectomy by laparoscopic assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH).
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E.2.2 | Secondary objectives of the trial |
Postoperative pain intensity at rest and movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU Total amount of intravenous piritramide used in the first 24h postoperative. - Quality of sleep during the first postoperative night, as measured by an 11-point NRS (where 0 = no sleep at all, and 10 = sleeping very well) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Patients between 18 and 70 years · Patients undergoing RARP, LAVH or TLH · ASA 1-3 · Scheduled as inpatient surgery (at least 1 night) · Body weight > 60 kg
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E.4 | Principal exclusion criteria |
· Refusal of the patient · Cognitive impairment or no understanding of the Dutch language · Allergy for salicylates or NSAID · Pregnancy · Active or history of peptic ulcer disease · History of gastro-intestinal hemorrhage or perforation · History of gastric bypass · History of renal disease with creatinine > 1 mg/dl · Haematological disease · Tromboctopenia < 150000 / µl · Current anticoagulant use · Current clopidogrel use · History of substance abuse or use of medication with a suppressive effect on the central nervous system
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary non-inferiority outcome measure is postoperative pain intensity at rest, as measured by an 11-point NRS (where 0 = no pain, and 10 = worst pain imaginable) at 8 hours after surgery (right before next dose of study medication). |
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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) |
Postoperative pain intensity at rest, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 12, 16 and 24 hours after surgery. - Postoperative pain intensity at movement, as measured by an 11-point NRS at other time points including at the Post Anesthesia Care Unit (PACU) discharge, 2, 4, 6, 8, 12, 16 and 24 hours after surgery. - Mean total postoperative intravenous piritramide consumption at PACU (milligram) - Total amount of intravenous piritramide used in the first 24h postoperative. Use of piritramide will be objectified by a patient controlled intravenous analgesia (PCIA) pump. Information on piritramide consumption will be extracted from the PCIA-system and analyzed using 4-hour intervals. - Quality of sleep during the first postoperative night, as measured by an 11-point NRS (where 0 = no sleep at all, and 10 = sleeping very well) - Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied). - GSR and EQ-5D, 1week postoperatively assessed with telephone-call - Adverse effects of ketorolac use or suspected by the use of ketorolac; GI-bleeding, acute kidney failure (defined as an increase in serum creatinine by 1,5), postoperative bleeding (defined as the necessity of packed cells transfusion or surgical relook), allergic reaction and asthma exacerbation.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2,4,6,8,12 and 16 hours after surgery |
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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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ketolorac in the regular dose (30 mg) |
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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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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 |