E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Colon cancer patients undergoing elective minimally invasive colon surgery and receiving a transversus abdominis plane block for postoperative pain management. Ropivacaine is used as the local analgetic injected and a saline solution is used as the placebo. |
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E.1.1.1 | Medical condition in easily understood language |
Pain after 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 | 21.1 |
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of the trial is to identify the “most simple non-inferior of three different methods”, placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound-guided transverse abdominal plane block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and LOS will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. - Age ≥ 18 years - Having given informed written consent. |
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E.4 | Principal exclusion criteria |
- Known allergy to local analgesics - Known liver failure Class C according to the Child-Pugh Score - Body weight of less than 40 kg - History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)19 - Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia - Predictably non-compliant due to language barrier or psychiatric disease - Patients rescheduled for open surgery, before the intervention has been administered - Patients where the indication for surgery changes before the intervention has been administered - Patients with known inflammatory bowel disease - Patients who have previously undergone open major abdominal surgery defined by prior intraabdominal surgery with a midline or upper abdominal incision of more than 8 cm - Incisional hernia - Patients with a history of abdominal wall surgery including resection of the external oblique muscles, the internal oblique muscles, the transversus abdominis muscles, the rectus abdominis muscles or their fascial components - Pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total morphine dose equivalents (intravenously in milligrams) administered in the first 24 hours from the end of anaesthesia. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after end of anaesthesia. |
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E.5.2 | Secondary end point(s) |
- Total morphine dose equivalents administered in the operating theatre - Total morphine dose equivalents administered in the post anaesthesia care unit (PACU) - Postoperative pain at rest (08:00–10:00 AM postoperative day 1 (POD 1)) - Postoperative pain when coughing (POD 1) - Postoperative length of stay (LOS) measured from the end of anaesthesia - Incidence of PONV (POD 1) - Total dose of antiemetic medication administered in the first 24 hours from the end of anaesthesia - Total dose of antiemetic medication administered in the operating theatre - Time spent in the PACU - Postoperative mobilisation (POD 1) - Quality of recovery (QoR-15) (POD 1) - Postoperative complications during the first 30 postoperative days according to the Clavien-Dindo classification of surgical complications - Need for rescue TAP-block or epidural analgesia.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Peroperative, discharge from PACU, POD 1, 24 hours after end of anaesthesia, discharge from hospital and POD 30. |
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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 | Yes |
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 | 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 | 3 |
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 | 5 |
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 | 4 |
E.8.9.1 | In the Member State concerned days | |