E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain relief following laparoscopic colorectal resectional surgery (Benign and malignant) |
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E.1.1.1 | Medical condition in easily understood language |
To assess the benefits of different methods of pain relief following laparoscopic colorectal surgery (i.e. removal of part of the large bowel for benign or malignant conditions) |
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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 | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036276 |
E.1.2 | Term | Postoperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 | 10021415 |
E.1.2 | Term | Immediate postoperative analgesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 use of a transversus abdominis plane (TAP) block reduce the total hospital length of stay after laparoscopic colorectal surgery? |
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E.2.2 | Secondary objectives of the trial |
Does the use of transversus abdominis plane blocks provide beneficial functional effects of reduced morphine such as time to first solid meal, time to mobilisation, reduction of nausea, vomiting and sedation? Does the use of transversus abdominis blocks provide adequate pain relief following laparoscopic colorectal surgery? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: All patients undergoing elective laparoscopic colorectal resectional procedures Patients undergoing colorectal procedure with or without stoma Patients of either sex Adult patients above 16 years of age Patients of any BMI Patients who have had neoadjuvant radiotherapy or chemoradiotherpay Patients of ASA I, ASA II and ASA III anaesthetic risk Patients who agree and sign the consent form to participate in this trial. |
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E.4 | Principal exclusion criteria |
Exclusion Criteria: Patients unable to give consent or refuse to participate in this study Patients under the age of 16 years Patients who are pregnant Patients undergoing an emergency operation Patients undergoing the procedure as a postoperative complication Procedures performed for complications or adverse events during the same hospital episode or performed in circumstances related to a primary and initial procedure. Patient is allergic to any medication used in local infiltration and/or morphine Patients with chronic pain syndrome Patients with severe hypotension such as cardiogenic or hypovolaemic shock Patients with severe hypertension. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is length of hospital stay. (in days) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start point: Operative intervention End point: Discharge from hospital |
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E.5.2 | Secondary end point(s) |
We will measure possible functional effects of reduced morphine usage. The variables investigated will be: Pain scores Nausea and vomiting levels Sedation levels Mood score (POMS) Complications of interventions Time to first meal Time to first mobilisation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
These variables will be assessed in the 48 hour postoperative period Length of stay will be assessed upon discharge |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Control group (i.e standard oral/intravenous analgesia) |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |