E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain suffered in the first 24 hours post vaginal hysterectomy |
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E.1.1.1 | Medical condition in easily understood language |
Pain suffered by women in the first 24 hours after surgery to remove their womb via the vagina |
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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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
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 |
Does the injection of local anaesthetic and adrenaline solution into the superficial tissue around the uterine cervix during vaginal hysterectomy reduce post-operative pain? |
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E.2.2 | Secondary objectives of the trial |
Does the injection of local anaesthetic and adrenaline (LA) solution into the superficial tissue of the uterine cervix during vaginal hysterectomy reduce blood loss during the operation, operating time, duration of inpatient stay and the incidence of post-operative infection and blood loss. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Female patient aged 18 years 2. Patients who will be undergoing vaginal hysterectomy 3. Capable of written informed consent in English 4. Patient is willing and able to complete pain scale questionnaire correctly
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E.4 | Principal exclusion criteria |
1. Patients undergoing any other concomitant procedure including and not limited to: -Any abdominal incisions e.g. laparoscopy/laparotomy; -Simultaneous mid-urethral tape insertion; -Concomitant sacrospinous ligament fixation (Vaginally applied uterosacral plication and McCall’s culdoplasty can be considered routine steps of a vaginal hysterectomy and are not reasons to exclude. Simultaneous pelvic floor repair is also not a reason to exclude); 2. Any patient who will receive a regional block e.g. Epidural, spine or TAP block 3. Patients with previous pelvic irradiation; 4. Patients with a history of previous pelvic floor surgery; 5. Patients who are allergic to analgesia on the international standardised post-operative analgesic prescription; 6. Patients using patient-controlled analgesia; 7. Patients who are allergic to local anaesthesia/adrenaline; 8. Patients who are already taking regular analgesia for chronic pain e.g. back or hip pain; 9. Patients taking anti-coagulation pre-operatively which would be highly active during the operation e.g. Aspirin/Clopidogrel five days prior to the operation date or Low-Molecular-Weight Heparin on day of the operation; 10. Patients treated with class III anti-arrhythmic drugs (e.g. Amiodarone); 11. Patients with partial or complete heart block – due to the fact that local anaesthetics may depress myocardial conduction; 12. Patients with advanced liver disease or severe renal dysfunction; 13. Any patient deemed unsafe for local anaesthetic by the anaesthetist; 14. Any patient who will receive Halogenate general anaesthesia for this pelvic floor surgery; and 15. Any patient who is pregnant; every patient who has consented for an elective hysterectomy will not be pregnant.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in pain score from Short-form McGill Pain questionnaire |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 3-6 hours post-operation 2. 24 hours post-operation |
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E.5.2 | Secondary end point(s) |
1. Estimated operative blood loss (EBL) from operating surgeon. 2. Change in pre and post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) assessing surgeon's perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. 6. Incidence of post-operative morbidity: -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Estimated operative blood loss (EBL)- all surgeons will document this immediately post-operatively 2. Change in pre and day 1 post-operative Hb and Hct as a marker of EBL 3. A visual analogue scale (VAS) completed by the operating surgeon immediately after the operation to state their perception of ease of dissection and ooze. 4. Time from knife to skin to end of operation for operating time 5. Duration of inpatient stay in days where 1 day would mean patient discharged any time the day after surgery etc. Tpo be completed in CRF once patient has been discharged off the ward. 6.Incidence of post-operative morbidity. To be completed after 6 weeks post-op. -Febrile morbidity most likely of vaginal/pelvic origin excluding UTI -Pelvic haematoma -Return to theatre
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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 | No |
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 | 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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 2 |