E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post operative pain following Total Abdominal Hysterectomy. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
|
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 |
We have recently described the Transversus Abdominis Plane (TAP) Block, a reliable approach to the blockade of the neural afferents to the anterior abdominal wall . These neural afferents course through the neurofascial plane between the internal oblique and the transversus abdominus muscles . Based on anatomic studies, our group has identified the lumbar triangle of Petit as a potential access point to this neurofascial plane. In this study, we aim to determine the analgesic efficacy of TAP blockade in the first 48 postoperative hours, in patients undergoing TAH, in a randomized controlled double blind clinical trial. |
|
E.2.2 | Secondary objectives of the trial |
Sedation Postoperative Nausea and Vomiting Patient Satisfaction Systemic absorption of Ropivacaine Effect on the stress response to surgery
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult Females aged >18 years old Presenting for elective Total Abdominal Hysterectomy Written Informed Consent ASA Grade 1 to 3
|
|
E.4 | Principal exclusion criteria |
Patient refusal Outside Age Range Allergy to bupivacaine, morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Measures: Severity of Postoperative Pain [VAS and Categorical pain Scales] Total opiate usage in the first 48 hours after surgery
Secondary Measures: Sedation Postoperative Nausea and Vomiting Patient Satisfaction
Tertiary Measures: Systemic absorption of Ropivacaine Effect on the stress response to surgery
|
|
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 | Yes |
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.8.3 |
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 | Information not present in EudraCT |
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
|
Study Size: We have recently demonstrated the analgesic efficacy of the TAP block in adults undergoing abdominal surgery. Based on this study, in order to demonstrate a difference of 25% in post-operative total analgesia consumption following abdominal surgery, at the 0.05 level of significance with a power of 0.8, we will require a minimum of 25 patients in each group. It is therefore planned to recruit 60 patients in total.
|
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |