Clinical trial NCT03238430: Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
Official title: Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Keywords: Intrathecal morphine, continuous wound infiltration
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morphine Consumption
timeFrame: During the first 24 hours post operative
Secondary outcomes:
measure: Morphine Consumption
timeFrame: During the 48 hours post operative
measure: Evaluation of postoperative pain intensity at rest
timeFrame: All 3 hours during the 48 postoperative hours
measure: Evaluation of postoperative pain intensity after activity
timeFrame: All 3 hours during the 48 postoperative hours
measure: Electric nociception threshold measured by PainMatcher
timeFrame: At the exit of Post Anesthesia Care Unit
measure: Electric nociception threshold measured by PainMatcher
timeFrame: At 24 hours post operative
measure: Electric nociception threshold measured by PainMatcher
timeFrame: At 48 hours post operative
measure: Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
timeFrame: At 3 months after surgery
measure: Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
timeFrame: At 6 months after surgery
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: At 3 months after surgery
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),
timeFrame: At 6 months after surgery
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
timeFrame: At 3 months after surgery
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
timeFrame: At 6 months after surgery
measure: Area peri-incisional hyperalgesia
timeFrame: At 48 hours post operative
measure: Number of nausea and/or vomiting episodes
timeFrame: At 24 hours after surgery
measure: Number of nausea and/or vomiting episodes
timeFrame: At 48 hours after surgery
measure: Number of nausea and/or vomiting episodes
timeFrame: At 72 hours after surgery
measure: Number of patient with side effect of morphine consumption
timeFrame: Up to 72 hours after surgery
measure: Time physiological function recovery
timeFrame: Up to the end of hospital stay, an average 10 days
measure: Length of hospital stay in intensive care unit
timeFrame: Up to the end of hospital stay,an average 10 days
measure: Length of hospital stay
timeFrame: Up to the end of hospital stay , an average 10 days
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU , Hôpital Claude Huriez
Study officials:
affiliation: CHRU de Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: