E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. |
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E.1.1.1 | Medical condition in easily understood language |
Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002182 |
E.1.2 | Term | Analgesia |
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 primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain in patients undergoing gynecological laparoscopic procedures in one-day surgery. |
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E.2.2 | Secondary objectives of the trial |
to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing opioid requirements. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who are planned for gynecological laparoscopic interventions on an ambulatory basis. |
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E.4 | Principal exclusion criteria |
- Less than 18 year old
- Weight less than 50 kg and more than 80 kg
- Pregnant
- Prisoners
- Allergic to topical anesthetics (Amides specifically)
- Allergic to Opioids as a class
- Currently or within the last 30 days been prescribed an opiate medication
- Chronic pain syndrome
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E.5 End points |
E.5.1 | Primary end point(s) |
- Post-operative pain intensity and opioid analgesic requirements.
- Post-operative shoulder pain intensity. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the postoperative stay in the ambulatory surgery unit.
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E.5.2 | Secondary end point(s) |
- Post-operative pain intensity from hospital discharge until 24 hrs post-operatively.
- Post-operative shoulder pain intensity from hospital discharge until 24 hrs post-operatively.
- Post-operative nausea and vomiting in the first 24 hrs post-operatively.
- Post-operative sedation until hospital discharge.
- Time until discharge from recovery room.
- Time until discharge from hospital.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Follow up is foreseen until 24 hrs post-operatively. |
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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 | No |
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 |
Control is a sole infiltration of portal sites, without the atomization of the peritoneal surface. |
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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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The day after surgery, the patient will be contacted by phone at home. She will be asked about (shoulder)pain, vomiting and nausea during the past 24 hours. After this contact, the study ends for this patient. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |