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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: intrathecal morphine; Drug: Morphine PCA; Drug: Ropivacaine infiltration

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHRU , Hôpital Claude Huriez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Gilles Lebuffe, MD, PhD, CHRU de Lille

Publications and helpful links

General Publications

• Rousseleau D, Plane B, Labreuche J, Pierache A, El Amine Y, Ethgen S, Wattier JM, Cirenei C, Boleslawski E, Lebuffe G. Comparison of catheter wound infusion, intrathecal morphine, and intravenous analgesia for postoperative pain management in open liver resection: randomized clinical trial. BJS Open. 2025 Jul 1;9(4):zraf074. doi: 10.1093/bjsopen/zraf074.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): May 25, 2019
• Study Completion (Actual): May 25, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Intrathecal morphine, continuous wound infiltration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: 2013_48; 2014-003317-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No