Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .

Study Overview
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Brief Summary
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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.

Official Title
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Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: intrathecal morphine
* Drug: Morphine PCA
* Drug: Ropivacaine infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgery of hepatic resection by first under costal. Patient classified ASA 1 to 3. Information, signed and informed consent Exclusion Criteria: Patients classified ASA 4 or 5. Allergy or intolerance to any of the products used in the protocol. Emergency surgery, palliative surgery, surgical recovery. History of chronic pain requiring the regular use of analgesics, especially opioids. History of drug misuse. Inability to understand and / or use the patient's self-controlled morphine pump. Known history of psychiatric disorders or current psychotropic treatment (excluding benzodiazepine monotherapy) Additive behavior with respect to alcohol or non-weaned psychodysleptic substances Pregnant Woman or Breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine infiltration<br>Continuous infiltration of local anesthetics + PCA morphine. | Drug: intrathecal morphine<br>* A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.<br>Drug: Morphine PCA<br>* a postoperative Morphine PCA<br>|
| Experimental: intrathecal morphine<br>Rachianalgesia + PCA morphine | Drug: Morphine PCA<br>* a postoperative Morphine PCA<br>Drug: Ropivacaine infiltration<br>* Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml<br>|
| Active Comparator: morphine PCA<br>PCA morphine alone | Drug: Morphine PCA<br>* a postoperative Morphine PCA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal morphine, continuous wound infiltration