E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post abdominal surgery pain |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
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 |
The TAP block has been shown to be an effective approach to analgesia post abdominal surgery. However studies to date have focused on single shot techniques and as such the analgesic results are time limited. We plan to pass epidural like catheters into the TAP bilterally under ultrasound guidance in healthy volunteers. Once position has been confirmed both sides will be bolused with local anaesthetic agent - lidocaine. The dermatomal spread of paraesthesia will be monitored on both sides. On one side an infusion of local anaesthetic agent (lignocaine 1%) will be commenced at a standard perineural catheter rate. On the other side at set time intervals boli of local anaesthetic agent (lignocaine 1%) will be administered and again the dermatomal spread of paraesthesia monitored. |
|
E.2.2 | Secondary objectives of the trial |
To determine if bolus or infusions provide better paraesthesia which relates to the provision of post-surgical analgesia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
aged 18 - 40 healthy ASA 1-2 |
|
E.4 | Principal exclusion criteria |
Pregnancy Allergy to amide type local anaesthetic agents Infection / lesions at the site of injection renal or other organ dysfunction Sepsis Heart Block (complete or partial) Acidosis Advanced liver disease Refusal |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is to monitor the dermatomal spread of paraesthesia following the injection of local anaesthetic agent (lidocaine 1%). We plan to investigate whether infusion of local anaesthetic agents provide denser, longer duration of action of paraesthesia than repeated boli. |
|
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
bolus versus infusion of local anaesthetic agent |
|
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 | 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
|
We plan to use 10 volunteers to assess the dermatomal spread and to define the best approach to maintaining the most complete paraesthesia. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 4 |