Pain, Postoperative
Conditions
Keywords
Intrathecal morphine, continuous wound infiltration
Brief summary
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.
Interventions
DRUGintrathecal morphine
A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
DRUGMorphine PCA
a postoperative Morphine PCA
Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | During the first 24 hours post operative | Morphine consumption is measured all 3 hours during the first 24 hours post operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of postoperative pain intensity at rest | All 3 hours during the 48 postoperative hours | The postoperative pain intensity is measured by Visual Analog Scale at rest |
| Evaluation of postoperative pain intensity after activity | All 3 hours during the 48 postoperative hours | The postoperative pain intensity is measured by Visual Analog Scale after activity |
| Electric nociception threshold measured by PainMatcher | At the exit of Post Anesthesia Care Unit | The Electric nociception threshold is measured by PainMatcher (CefarCompex®) |
| Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA) | At 3 months after surgery | Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ Mac Gill bread questionary) |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI) | At 3 months after surgery | Evaluation with validated score for chronic and neuropathic pains (NPSI) |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI), | At 6 months after surgery | Evaluation with validated score for chronic and neuropathic pains (NPSI) |
| Morphine Consumption | During the 48 hours post operative | Morphine consumption is measured all 3 hours during the 48 hours post operative |
| Area peri-incisional hyperalgesia | At 48 hours post operative | The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament. |
| Number of nausea and/or vomiting episodes | At 24 hours after surgery | Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics |
| Number of patient with side effect of morphine consumption | Up to 72 hours after surgery | Respiratory Depression, Urinary retention, Prurit |
| Time physiological function recovery | Up to the end of hospital stay, an average 10 days | Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk |
| 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 | — |
| Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2), | At 3 months after surgery | Evaluation with validated score for chronic and neuropathic pains (DN2) |
Countries
France
Outcome results
None listed