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Evaluation of the benefit of non-opioid general anaesthesia on postoperative pain in laparoscopic colonic surgery
Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with morphine | Active Comparator | conventional general anaesthesia with morphine |
|
| Group without opiates | Experimental | general anaesthesia without opiates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anaesthesia without opiates | Drug | Anaesthesia without opiates for patients undergoing laparoscopic colectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Use | All intravenous and oral morphine consumed in the first 48 hours after surgery | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain H12 | Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department. | Hour 12 |
| Postoperative pain H24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Médipôle | Villeurbanne | 69100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39393528 | Derived | Collange V, Berruet JB, Aubrun F, Poiblanc M, Olagne E, Golliet Mercier N, Parent S, Noel P, Devillez S, Perrou M, Ramadan J, Coeckelenbergh S, Joosten A. Opioid free versus opioid sparing strategies for multimodal antinociception during laparoscopic colectomy: a randomised controlled trial. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101436. doi: 10.1016/j.accpm.2024.101436. Epub 2024 Oct 9. |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D053610 | Opiate Alkaloids |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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Single-centre prospective randomised study carried out in two parallel groups of patients undergoing laparoscopic colectomy.
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The patient does not know which treatment is used for the anesthesia
| anaesthesia with morphine | Drug | anaesthesia with morphine for patients undergoing laparoscopic colectomy |
|
Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department.
| Hour 24 |
| Postoperative pain H36 | Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department. | Hour 36 |
| Postoperative pain H48 | Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department. | Hour 48 |
| Postoperative pain D30 | Postoperative pain will be reported by the nursing staff on a simple numerical scale graduated from 0 to 10 after questioning the patient, according to the usual procedures of the department. | Day 30 |
| Mean arterial pressure | Mean arterial pressure (MAP) (mmHg) | 48 hours |
| Mean arterial pressure variability | MAP variability in percentage | 48 hours |
| Duration of Mean arterial pressure <65 | Duration of Mean arterial pressure <65 mmHg (min) | 48 hours |
| Duration of Mean arterial pressure <55 | Duration of Mean arterial pressure <65 mmHg (min) | 48 hours |
| Average heart rate | Average heart rate | 48 hours |
| Heart rate variability | Heart rate variability in percentage | 48 hours |
| Bradycardia duration < 50 | Bradycardia duration < 50 (min) | 48 hours |
| Atropine dose administered | Atropine dose administered (mg) | 48 hours |
| Ephedrine dose administered | Ephedrine dose administered (mg) | 48 hours |
| Noradrenaline dose administered | Noradrenaline dose administered (ug) | 48 hours |
| Neosynephrine dose administered | Neosynephrine dose administered (ug) | 48 hours |
| Urapidil dose | Urapidil dose (mg) | 48 hours |
| Nicardipine dose | Nicardipine dose (mg) | 48 hours |
| Postoperative hypoxemia | Postoperative hypoxemia (Yes/No) | 48 hours |
| Consumption of non-morphine drug | Consumption of NSAIDs, nefopam, tramadol, ondansetron and other antiemetics | Day 90 |
| Assessment of tolerance | All adverse events will be collected and compared between the 2 groups | Day 90 |
| Assessment of disability | Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0) | Day 30 |
| Assessment of disability | Assessment of disability with the World Health Organization Disability Assessment Schedule (WHODAS2.0). Evolution between Day 30 and Day 90. | Day 90 |
| Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay | Time to extubation, time to resumption of transit, time to onset of first gas, length of stay in ICU and total length of hospital stay | Day 90 at least |
| Immediate postoperative hypoxemia | Immediate postoperative hypoxemia | Day 1 |
| Oxygen requirement | Oxygen requirement (yes/no at D0, D1, D2) | Day 2 |
| D009019 |
| Morphinans |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |