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

University Hospital, Lille

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Morphine PCA; Drug: intrathecal morphine; Drug: Ropivacaine infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT03238430

2014-003317-28 (EudraCT Number)

2013_48

Details and patient eligibility

About

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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

Ropivacaine infiltration

Experimental group

Description:

Continuous infiltration of local anesthetics + PCA morphine.

Treatment:

Drug: intrathecal morphine

Drug: Morphine PCA

intrathecal morphine

Experimental group

Description:

Rachianalgesia + PCA morphine

Treatment:

Drug: Ropivacaine infiltration

Drug: Morphine PCA

morphine PCA

Active Comparator group

Description:

PCA morphine alone

Treatment:

Drug: Morphine PCA