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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003317-28 | EudraCT Number |
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Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative.
The study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine infiltration | Experimental | Continuous infiltration of local anesthetics + PCA morphine. |
|
| intrathecal morphine | Experimental | Rachianalgesia + PCA morphine |
|
| morphine PCA | Active Comparator | PCA morphine alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal morphine | Drug | A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption | Morphine consumption is measured all 3 hours during the first 24 hours post operative | During the first 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption | Morphine consumption is measured all 3 hours during the 48 hours post operative | During the 48 hours post operative |
| Evaluation of postoperative pain intensity at rest | The postoperative pain intensity is measured by Visual Analog Scale at rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Lebuffe, MD, PhD | CHRU de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU , Hôpital Claude Huriez | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40662757 | Result | Rousseleau D, Plane B, Labreuche J, Pierache A, El Amine Y, Ethgen S, Wattier JM, Cirenei C, Boleslawski E, Lebuffe G. Comparison of catheter wound infusion, intrathecal morphine, and intravenous analgesia for postoperative pain management in open liver resection: randomized clinical trial. BJS Open. 2025 Jul 1;9(4):zraf074. doi: 10.1093/bjsopen/zraf074. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Morphine PCA | Drug | a postoperative Morphine PCA |
|
| Ropivacaine infiltration | Drug | Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml |
|
| All 3 hours during the 48 postoperative hours |
| Evaluation of postoperative pain intensity after activity | The postoperative pain intensity is measured by Visual Analog Scale after activity | All 3 hours during the 48 postoperative hours |
| Electric nociception threshold measured by PainMatcher | The Electric nociception threshold is measured by PainMatcher (CefarCompex®) | At the exit of Post Anesthesia Care Unit |
| Electric nociception threshold measured by PainMatcher | The Electric nociception threshold is measured by PainMatcher (CefarCompex®) | At 24 hours post operative |
| Electric nociception threshold measured by PainMatcher | The Electric nociception threshold is measured by PainMatcher (CefarCompex®) | At 48 hours post operative |
| Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA) | Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary") | At 3 months after surgery |
| Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA) | Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary") | At 6 months after surgery |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI) | Evaluation with validated score for chronic and neuropathic pains (NPSI) | At 3 months after surgery |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI), | Evaluation with validated score for chronic and neuropathic pains (NPSI) | At 6 months after surgery |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2), | Evaluation with validated score for chronic and neuropathic pains (DN2) | At 3 months after surgery |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2), | Evaluation with validated score for chronic and neuropathic pains (DN2) | At 6 months after surgery |
| Area peri-incisional hyperalgesia | The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament. | At 48 hours post operative |
| Number of nausea and/or vomiting episodes | Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics | At 24 hours after surgery |
| Number of nausea and/or vomiting episodes | Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics | At 48 hours after surgery |
| Number of nausea and/or vomiting episodes | Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics | At 72 hours after surgery |
| Number of patient with side effect of morphine consumption | Respiratory Depression, Urinary retention, Prurit | Up to 72 hours after surgery |
| Time physiological function recovery | Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk | Up to the end of hospital stay, an average 10 days |
| Length of hospital stay in intensive care unit | Up to the end of hospital stay,an average 10 days |
| Length of hospital stay | Up to the end of hospital stay , an average 10 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |