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

December 15, 2025 updated by: University Hospital, Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
During the first 24 hours post operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine Consumption
Time Frame: During the 48 hours post operative
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
Time Frame: All 3 hours during the 48 postoperative hours
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
Time Frame: All 3 hours during the 48 postoperative hours
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
Time Frame: At the exit of Post Anesthesia Care Unit
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
At the exit of Post Anesthesia Care Unit
Electric nociception threshold measured by PainMatcher
Time Frame: At 24 hours post operative
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
At 24 hours post operative
Electric nociception threshold measured by PainMatcher
Time Frame: At 48 hours post operative
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)
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")
At 3 months after surgery
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")
At 6 months after surgery
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)
At 3 months after surgery
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)
At 6 months after surgery
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)
At 3 months after surgery
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)
At 6 months after surgery
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.
At 48 hours post operative
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
At 24 hours after surgery
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
At 48 hours after surgery
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
At 72 hours after surgery
Number of patient with side effect of morphine consumption
Time Frame: Up to 72 hours after surgery
Respiratory Depression, Urinary retention, Prurit
Up to 72 hours after surgery
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
Up to the end of hospital stay, an average 10 days
Length of hospital stay in intensive care unit
Time Frame: Up to the end of hospital stay,an average 10 days
Up to the end of hospital stay,an average 10 days
Length of hospital stay
Time Frame: Up to the end of hospital stay , an average 10 days
Up to the end of hospital stay , an average 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilles Lebuffe, MD, PhD, CHRU de Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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