E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The pain study:
To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions.
The safety study:
To evaluate the importance of deep neuromuscular blockade (NMB) in laparoscopic hysterectomy considering the number unintended and unwanted patient movements registered by the surgeon.
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Smertestudiet:
At undersøge effekten af dyb neuromuskulær blokade (NMB) og lavt intraabdominalt tryk ved laparoskopisk hysterektomi på postoperative smerter, kvalme og analgetikaforbrug samt indlæggelsesvarighed og tid før genoptagelse af normale funktioner.
Sikkerhedsstudiet:
At undersøge effekten af dyb neuromuskulær blokade på antal tilfælde af utilsigtede bevægelser af abdomen registreret af kirurgen.
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E.1.1.1 | Medical condition in easily understood language |
Recovery after laparoscopic removal of the uterus with muscle relaxation and low abdominal pressure |
Smerter efter gynækologisk kikkertoperation med muskelafslappende middel og lavt tryk i bughulen |
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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 |
The pain study:
To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative shoulderpain
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E.2.2 | Secondary objectives of the trial |
To evaluate the importance of deep neuromuscular blockade (NMB) and low intraabdominal pressure in laparoscopic hysterectomy considering postoperative pain, nausea, consumption of analgetics, lengths of hospital stay and time to recover to normal functions. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
The safety study:
To evaluate the importance of deep neuromuscular blockade (NMB) in laparoscopic hysterectomy considering the number unintended and unwanted patient movements registered by the surgeon.
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E.3 | Principal inclusion criteria |
Patients > 18 years old
Elective laparoscopic hysterectomy (total/subtotal)
Can read and understand Danish
Informed consent
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E.4 | Principal exclusion criteria |
BMI > 28 kg/cm2
Known allergy to medications that are included in the project
Severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
Neuromuscular disease that may interfere with neuromuscular data
Lactating or pregnant
Impaired liver function
Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of shoulder pain or discomfort in the shoulder region within 14 days after operation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
14 days after hysterectomy |
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E.5.2 | Secondary end point(s) |
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation
Number of days before resumption of daily acitivities
Number of days before resumption of work
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 4 days after operation
Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve from preoperatively till 14 days after operation
Number of days before resumption of daily acitivities
Number of days before resumption of work
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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 | 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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |