E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The postoperative pain and morphine consumption after Total Laparoscopic Hysterectomy |
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E.1.1.1 | Medical condition in easily understood language |
The postoperative pain and morphine consumption after Total Laparoscopic Hysterectomy |
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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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 100000004863 |
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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 |
Aim: Our aim with this study is to investigate the efficacy of the Ultrasound-guided (USG) Transmuscular Quadratus Lumborum (TQL) block vs. Placebo in patients undergoing Total Laparoscopic Hysterectomy (TLH). Our hypothesis is that the bilateral TQL block will significantly reduce the opioid consumption during the first 12 postoperative hours.
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E.2.2 | Secondary objectives of the trial |
Our hypothesis is that the bilateral TQL block will significantly reduce the Numerical Rating Scale (NRS) pain score (0-10/10), opioid related side effects, times to first opioid and times to ambulation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Participants in the study should fullfil the following criteria in order to be included: - Scheduled for TLH - Age > 17 years at the date of inclusion Have received thorough information, orally and in written, and signed the “Informed Consent” form on participation in the trial
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E.4 | Principal exclusion criteria |
Exclusion criteria: Either of the following criteria will lead to exclusion of the patient of the study: Inability to cooperate Inability to speak, read and understand Danish Allergy to local anaesthetics or opioids Daily intake of opioids, according to the investigators decision Local infection at the site of injection or systemic infection Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration Co-morbidity, ASA>3 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome of the study will be: Morphine consumption in the first 12 postoperative hours (data from PCA pump and the patient’s medical record). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Twelve hours after arrival at the Post Anesthesia Care Unit (PACU) |
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E.5.2 | Secondary end point(s) |
The secondary outcomes will be: (A) Pain intensity (NRS 0-10/10) in the study period at T0 (arrival in the PACU), after 15, 30 and 45 minutes. And again at 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 21 and 24 hours postoperatively. In addition, NRS score for pain will be recorded electronically in relation to all morphine administrations, since all patients must enter their NRS pain score on the Patient-Controlled-Analgesia (PCA) pump display in relation to administration of the PCA boluses. (B) Total morphine consumption. Morphine consumption at 3, 6, 9, 12, 18 and 24 postoperative hours. (C) Duration of block (time to first opioid). (D) Patient satisfaction with application of the block. (E) The degree of morphine-related side effects (PONV, itching, fatigue, etc.). (F) Time from operation to ambulation.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Twentyfour hours after arrival at the Post Anesthesia Care Unit |
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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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |