E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will involve the continuous infusion of local anaesthetic, into either the rectus sheath space, or the preperitoneal space, in order to achieve optimal analgesia for patients who have undergone a laparotomy. We will compare analgesic efficacy of these techniques over the first 72 hours in the postoperative period. |
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E.1.1.1 | Medical condition in easily understood language |
We will be comparing the effect of two methods of local anaesthetic pain relief in the management of acute postoperative pain, in patients who have undergone major abdominal surgery. |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 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 |
To compare the analgesic efficacy of continuous preperitoneal wound catheter infiltration of local anaesthetic, and continuous rectus sheath blockade, for the management of postoperative pain in the first 72 hours following laparotomy. The primary outcome is total morphine consumption in the first 72 hours. |
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E.2.2 | Secondary objectives of the trial |
Continuous infusion of local anaesthetic via a continuous thoracic epidural is the gold standard for the management of post-laparotomy pain. This is often combined with the use of opiates e.g. morphine. However, in many cases, due to both intrinsic patient factors, and external influences, an epidural may not be feasible. Morphine, and other opiates, have many unwanted side-effects that can result in morbidity e.g. itch, nausea+vomiting, sedation, constipation, urinary retention, respiratory depression etc. Two techniques that have been used, when central neuraxial analgesia is not possible, are the continuous bilateral rectus sheath blockade and the continuous bilateral preperitoneal wound catheter infiltration device. We plan, not only to show evidence of a reduction in total opiate consumption, but also evidence of lower complication rates, shorter high-dependency unit and inpatient stays, and reduced anaesthetic and recovery time, and high patient satisfaction.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult general surgical patients presenting for laparotomy ASA 1 to 4 Written informed consent
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E.4 | Principal exclusion criteria |
Patient refusal. Local infection at site of insertion. Allergy to amide local anaesthetics, opioids, paracetamol, NSAIDs, ketamine, NMBs, volatile anaesthetics. Concurrent use of antiarrhythmics with local anaesthetic activity. Concurrent use of MAOIs or within 2 weeks of MAOI use. Severe liver or cardiac dysfunction. Inability to comprehend pain scoring system. Elderly or debilitated patients that require a reduction in levobupivacaine dose commensurate with their physical status, resulting in the protocol not being followed. Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Total postoperative opioid consumption in the first 72 hours. All data will be collected by an investigator blinded to group allocation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively. |
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E.5.2 | Secondary end point(s) |
Postoperative pain scores, at rest and on movement as defined by the study authors, recorded at 6 – hourly intervals in the first 72 hours after surgery. (VAS and Categorical pain Scales) •Sleep quality o 10 – point visual analogue scale; 0 = very poor, 10 = excellent •Cardiovascular haemodynamics o 6 – hourly MAP, estimated blood loss (EBL), transfusion requirements •Respiratory function •Opioid side – effects: o Sedation, Postoperative nausea, vomiting, itch. •Time to return of bowel function as defined by: o Duration of postoperative ileus or number of participants with “ileus”. o Aspirate measurement from NG. o Time to first flatus, or number of participants with delay to first flatus. o Time to first bowel motion. o Time to first oral intake, or number of participants with delay to oral intake. •Duration of hospital stay (synthetic index of recovery). •Participant acceptability of analgesic method. •Participant satisfaction with analgesia. •Resource use i.e. cost/benefit analysis.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessments will be made intraoperatively and 1, 2, 4, 6, 12, 24, 48, and 72 hours post operatively. |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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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The trial will be ended when 60 patients have been recruited into each group. We plan to conduct an interim analysis for futility once 60 patients have been enrolled into the study. The study will be terminated in the event that the analysis of 72 hour morphine consumption demonstrates that morphine consumption is 25% higher in the wound catheter group, with a p value < 0.01. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |