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Completed

NCT Number: NCT03238430

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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHRU , Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal morphine

Drug

A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.

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

Primary outcomes

  1. Morphine Consumption

    Time frame: During the first 24 hours post operative

    Morphine consumption is measured all 3 hours during the first 24 hours post operative

Secondary outcomes

  1. Morphine Consumption

    Time frame: During the 48 hours post operative

    Morphine consumption is measured all 3 hours during the 48 hours post operative

  2. Evaluation of postoperative pain intensity at rest

    Time frame: All 3 hours during the 48 postoperative hours

    The postoperative pain intensity is measured by Visual Analog Scale at rest

  3. Evaluation of postoperative pain intensity after activity

    Time frame: All 3 hours during the 48 postoperative hours

    The postoperative pain intensity is measured by Visual Analog Scale after activity

  4. Electric nociception threshold measured by PainMatcher

    Time frame: At the exit of Post Anesthesia Care Unit

    The Electric nociception threshold is measured by PainMatcher (CefarCompex®)

  5. Electric nociception threshold measured by PainMatcher

    Time frame: At 24 hours post operative

    The Electric nociception threshold is measured by PainMatcher (CefarCompex®)

  6. Electric nociception threshold measured by PainMatcher

    Time frame: At 48 hours post operative

    The Electric nociception threshold is measured by PainMatcher (CefarCompex®)

  7. Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)

    Time frame: 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")

  8. Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)

    Time frame: At 6 months after surgery

    Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")

  9. Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)

    Time frame: At 3 months after surgery

    Evaluation with validated score for chronic and neuropathic pains (NPSI)

  10. Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),

    Time frame: At 6 months after surgery

    Evaluation with validated score for chronic and neuropathic pains (NPSI)

  11. Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),

    Time frame: At 3 months after surgery

    Evaluation with validated score for chronic and neuropathic pains (DN2)

  12. Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),

    Time frame: At 6 months after surgery

    Evaluation with validated score for chronic and neuropathic pains (DN2)

  13. Area peri-incisional hyperalgesia

    Time frame: At 48 hours post operative

    The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.

  14. Number of nausea and/or vomiting episodes

    Time frame: At 24 hours after surgery

    Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics

  15. Number of nausea and/or vomiting episodes

    Time frame: At 48 hours after surgery

    Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics

  16. Number of nausea and/or vomiting episodes

    Time frame: At 72 hours after surgery

    Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics

  17. Number of patient with side effect of morphine consumption

    Time frame: Up to 72 hours after surgery

    Respiratory Depression, Urinary retention, Prurit

  18. Time physiological function recovery

    Time frame: 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

  19. Length of hospital stay in intensive care unit

    Time frame: Up to the end of hospital stay,an average 10 days

  20. Length of hospital stay

    Time frame: Up to the end of hospital stay , an average 10 days

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: CATHEPAT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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